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NEW YORK

Drug Safety Specialist – Westbury, NY

JOB QUALIFICATIONS:

  • Bachelor’s degree in science or related discipline.
  • 1-3 years health care, pharmaceutical or pharmacy experience.
  • Basic competence with medical and therapeutic terminology.
  • Ability to work independently but guided by documented procedures, with appropriate support.
  • Able to work effectively as part of a team.
  • Understanding of patient safety regulatory obligations.
  • Familiar with regulatory & pharmacovigilance guidelines will be a plus
  • Excellent attention to detail.
  • Ability to deliver within established timelines.
  • Fluency in English and excellent comprehension.
  • Computer literate.
  • Experience with relevant software applications will be a plus

POSITION RESPONSIBILITIES:

  • Record and monitor consumer complaints and initiate investigations
  • Provide a written response to the consumer providing pharmacovigilance at the consumer level as needed
  • Work and assist medical advisors as needed
  • Generate a MedWatch report as a result of an adverse event
  • Answer consumers’ technical questions related to the product
  • Assist the Drug Safety Manager or delegates as required
  • Provide pharmacovigilance knowledge as required
  • Assist in other functions in the department as needed
  • Prepare trending reports

 

Network Engineer – Westbury, NY

JOB QUALIFICATIONS:

· 5 years equivalent work experience.

· Certifications in Cisco (CCENT, CCNA) required

· Ability to design network diagrams for new network rollouts and existing network deployments

· Ability to perform any IOS upgrades and apply any needed security patches to internetworking equipment

· Working technical knowledge of network and PC operating systems, including Windows XP Professional, Windows 7 Professional, Linux Red Hat, Mac OS X.

· Extensive application support experience with network protocol analyzers such as Wireshark and SolarWinds.

· Working technical knowledge of current network hardware, protocols, and standards, including Cisco switches, routers, firewalls, TCP/IP, DNS, DHCP, LAN/WAN technologies, WLAN technologies, VOIP.

· Ability to operate network component analyzers, scanners, and testers.

· Hands-on hardware troubleshooting experience.

· Understanding of the organization’s goals and objectives.

· Strong written and oral communication skills and good interpersonal skills.

· Ability to conduct research into networking issues and products as required.

· Ability to present ideas in user-friendly language.

· Self motivated and directed with keen attention to detail.

· Analytical and problem-solving abilities.

· Ability to effectively prioritize and execute tasks in a high-pressure environment.

· Strong customer service orientation.

· Experience working in a team-oriented, collaborative environment.

· On-call availability

· Sitting for extended periods of time.

· Inspect and install cables in floors and ceilings.

· Some travel required

· Lifting and transporting of heavy to moderately heavy objects, such as computers and peripherals.

POSITION RESPONSIBILITIES:

· Collaborate with internal and/or external network analysts and designers to create optimal network design topologies and configurations.

· Work with end users and department heads to identify and document required network service levels. Work to meet service level agreements with end users.

· Aid in development of business continuity and disaster recovery plans, and maintain current knowledge of plan executables. Respond to emergency network outages in accordance with business continuity and disaster recovery plans.

· Prepare and ensure accuracy of documentation, procedures manuals, and help sheets for network installations, including data, voice, and video systems.

· Support development and implementation of networking projects and new technology installations.

· Conduct research on network products, services, protocols, and standards in support of network procurement and development efforts. Evaluate and recommend for purchase networking hardware and software products.

· Write technical specifications for purchase of networking hardware and software products.

· Maintain up-to-date knowledge of networking contracts and supervise contract-based installations.

· Monitor and maintain uptime between all sites

· Maintain security solutions, including firewall, anti-virus, and intrusion detection systems.

· Maintain all network hardware and equipment, including routers, switches, hubs, and UPSs.

· Monitor and test network performance and provide network performance statistics and reports.

· Receive and respond to incoming calls, alerts, and/or e-mails regarding network connectivity problems.

· Perform on-site analyze, diagnosis, and resolution of complex network problems for a variety of end users, and recommend and implement corrective hardware and software solutions, including off-site repair.

· Recommend, schedule, and perform network improvements, upgrades, and repairs.

· Practice network asset management, including maintenance of network component inventory.

· Prepare, maintain, and adhere to procedures for logging, reporting, and statistically monitoring network data.

· Liaise with, and provide training and support to, help desk support staff on network issues.

· Perform server and security audits.

· Perform system backups and recovery.

· Provide guidance to junior members of the team as required.

IT Support Analyst – Westbury, NY

JOB QUALIFICATIONS:

  • 3 years equivalent work experience.
  • Certifications in A+, CompTIA Network +, MCDST preferred but not required.
  • Knowledge of basic computer hardware, including workstations, laptops, printers, copiers, wireless technologies, handheld scanners, thermal printers, smartphones, VOIP.
  • Experience with desktop and server operating systems, including Windows XP Professional, Windows 7 Professional, Mac OS X, Linux Red Hat, Windows Mobile, Windows Server 2003/2008.
  • Extensive application support experience with MS Office Suite, Oracle.
  • Working knowledge of a range of diagnostic utilities, including Putty, Wireshark, SolarWinds, VNC, RDP .
  • Familiarity with the fundamental principles of a validated computer environment
  • Exceptional written and oral communication skills.
  • Exceptional interpersonal skills, with a focus on rapport-building, listening and questioning skills.
  • Strong documentation skills.
  • Fluent English and Spanish language skills a plus.
  • Ability to conduct research into a wide range of computing issues as required.
  • Ability to absorb and retain information quickly.
  • Ability to present ideas in user-friendly language.
  • Highly self-motivated and directed.
  • Keen attention to detail.
  • Proven analytical and problem-solving abilities.
  • Ability to effectively prioritize and execute tasks in a high-pressure environment.
  • Exceptional customer service orientation.
  • Experience working in a team-oriented, collaborative environment.
  • 40-hour on-site work week.
  • Sitting for extended periods of time.
  • Dexterity of hands and fingers to operate a computer keyboard, mouse, power tools, and other computer components.
  • Lifting and transporting of moderately heavy objects, such as computers and peripherals.
  • Some travel required between multiple warehouse sites

POSITION RESPONSIBILITIES:

  • Evaluate documented resolutions and analyze trends for ways to prevent future problems.
  • Alert management to emerging trends in incidents.
  • Assist in software releases and roll-outs and communication to the end users.
  • Field incoming requests to the Help Desk via both telephone and e-mail and Kaseya to ensure courteous, timely and effective resolution of end user issues.
  • Document all pertinent end user identification information, including name, department, contact information and nature of problem or issue.
  • Prioritize and schedule problems. Escalate problem (when required) to the appropriately experienced technician.
  • Record, track and document the service desk request problem-solving process, including all successful and unsuccessful decisions made, and actions taken, through to final resolution.
  • Apply diagnostic utilities to aid in troubleshooting.
  • Access software updates, drivers, knowledge bases, and FAQ resources on the Internet/Intranet to aid in problem resolution.
  • Identify and learn appropriate software and hardware used and supported by the organization.
  • Perform hands-on fixes at the desktop level, including installing and upgrading software, installing hardware, implementing file backups, and configuring systems and applications.
  • Install anti-virus software and ensure virus definitions are up-to-date.
  • Perform preventative maintenance, including checking and cleaning of workstations, printers, and peripherals.
  • Test fixes to ensure problem has been adequately resolved.
  • Perform post-resolution follow ups to help requests.
  • Develop help sheets, how to videos, and FAQ lists for end users.
  • Reinforce SLAs to manage end-user expectations.

Regulatory Affairs Specialist – Westbury, NY

JOB QUALIFICATIONS:

  • BA/BS degree in life sciences field. MS degree preferred.
  • 3-5 years of experience gained working in Regulatory Affairs in the pharmaceutical/ Medical Device industry.
  • Successful experience with creating, reviewing and submitting ANDA submissions via ESG and responding to deficiencies from FDA.
  • Knowledge of CFR (Code of Federal Regulations) for drug, device, nutritionals, dietary supplements, tobacco products etc.,
  • Excellent communication skills (Verbal and writing).
  • Strong technical CMC knowledge and Project Management skills.
  • Ability to research regulations and guidance documents from all relevant enforcement agencies and preparing execution and compliance plans.
  • The ability and willingness to travel domestically and internationally as required.

POSITION RESPONSIBILITIES:

  • Collaborate with internal and external teams to gather, review, assemble documents required for original ANDA submissions, amendments, supplements, tech transfers and annual reports.
  • Create project reports and track progress and milestones for all Regulatory Projects to ensure timely submission as per Goals/Priorities created by Management.
  • Provide input and create strategy for all post approval changes for PLD ANDA’s, tech transfers and due diligence request for new products.
  • Provide input into strategic planning to achieve global, regional and departmental goals for development projects and Regulatory lifecycle management.
  • Create and maintain all relevant Federal and State registrations as required.
  • Provide Regulatory input to Label Development team for labeling questions which include but not limited to CFR and guidance documents.
  • Work with internal and external teams to help with Country of Origin determinations.
  • Act as a Regulatory backup reviewer for Label Development department.
  • Monitor FDA and other relevant enforcement agencies to ensure timely implementation of new guidance’s, labeling changes, product safety surveillance etc.,
  • Review and maintain NDC listings.
  • Review and maintain 510 (K) submissions, Tobacco product registrations, Fertilizer registrations.
  • Prepare documents for claim substantiation for dietary supplements, drug products, medical devices, tobacco products etc.,
  • Make routine decisions and as appropriate raise situations/ trends to Management; expected to make recommendations for situations and trends.
  • Other duties as assigned by Management.

Sr Financial Analyst – Westbury, NY

Job Qualifications:

· Bachelor’s degree in Accounting, Finance, Mathematics or Economics (Master’s preferred)
· 5+ years experience in reporting, consolidation, and financial analysis
· Accounting and GAAP knowledge
· Proficient in Microsoft Office (specifically Excel)
· Excellent verbal and written communication skills
· Organized, detail oriented, strategically focused
· Ability to effortlessly multi-task in a fast-paced, constantly evolving environment
· Knowledge of Hyperion is a plus

Position Responsibilities:

· Develop detailed annual budget and proactively identify opportunities for improvement
· Assist in the month-end close process
· Prepare, review and analyze monthly financial statements
· Provide monthly and quarterly reporting to external stakeholders and analytical support to ensure financial compliance
· Track expenses and revenues and analyze Actual to Plan variances
· Evaluate margins at individual SKU level
· Provide corporate analytics to support strategic decisions from executive management team

OLM/GMP Training Generalist – Westbury, NY

JOB QUALIFICATIONS:

  • High School Diploma required
  • Bilingual English/Spanish required
  • Ability to proofread both English and Spanish documents to ensure there are no spelling or grammatical errors
  • Oracle and Agile experience preferred
  • MS Excel skills
  • Familiar with standard concepts, practices, and procedures within the pharmaceutical OTC industry
  • Ability to think strategically and manage multiple projects and tasks
  • Ability to train people (public speaking)

POSITION RESPONSIBILITIES:

  • Support the OLM/GMP Training Team as needed
  • Serve as the GMP Trainer and Coordinator for Annual and New Hire cGMP training
  • Work with Document Control personnel to proofread new and revised documents in Agile, both English and Spanish documents
  • Enter data into Oracle Learning Management
  • Conduct follow ups with employees for missing training
  • Scan and attach attendance sheets to classes in OLM when required
  • File attendance sheets and superseded/obsoleted document control material. Maintain all cabinets in the file room for our team in an organized and up to date manner

Process Operator I – Copiague, NY

JOB QUALIFICATIONS:

  • High school diploma or equivalent
  • One (1) year of work experience in a manufacturing environment preferred.
  • Record keeping and basic math skills.
  • Use of different units of measurement (i.e. weight, size, volume).
  • The ability to read, write and speak English.
  • Clear and concise communication, both orally and in writing.
  • The ability to work independently as well as in a team environment.

POSITION RESPONSIBILITIES:

  • Reports process or equipment problems to supervisor; performs general troubleshooting.
  • Ensures batch records, equipment log books, and other relevant records are current; performs batch record reconciliation.
  • Sets up and operates equipment for processing operations.
  • Cleans and maintains processing rooms and equipment.
  • Monitors process and equipment and makes necessary adjustments to maintain batch record specifications.
  • Monitors product quality.
  • Follows established department SOP’s and batch record instructions; assists in SOP and batch record revisions.
  • Complies with all Company policies and procedures, including safety rules and regulations.
  • Performs additional duties as assigned.

Line Material Handler – Westbury, NY

JOB QUALIFICATIONS:

  • Ability to lift, pull or push up to 70 pounds
  • Must be able to work in a fast-paced production environment
  • Ability to do repetitive motions for long periods of time
  • Ability to work standing/walking for extended periods of time
  • Must be able to follow written instructions

POSITION RESPONSIBILITIES:

  • Responsible for adhering to company rules and directions given by the Line Leader or Backup Line Leader
  • Using a hand jack brings scheduled components to the line and stocks components to be used according to the lowest lot number first
  • Keep all machinery inside of the filling room of the bottling lines fed with components to maintain the line running efficiently
  • Review packaging specification and pick slip during start-up to assure product is being packaged as specified
  • Responsible for the proper operation of machines in their zone and assures machines are producing a quality product free of defects
  • Communicate to Line Leader and/or Backup Line Leader any issues pertaining to the quality of the product, safety concerns and machinery malfunctions
  • Foster a teamwork environment by supporting and respecting peers
  • Assist in monitoring and training new employees for On The Job Training (OJT)
  • Ensure the line is always well maintained, clean and clutter-free throughout the day
  • Responsible for cleaning up zone area first during changeovers and upon completion assists fellow coworkers with their zones in order to expedite the changeover
  • Count returns and rejects by weight or physical count and enters them into the batch record
  • Deliver returns to the reconciliation area and places components in the specified area

Quality Control Inspector – Westbury, NY

JOB QUALIFICATIONS:
•0 – 2 years experience in related field
•Knowledge of FDA/cGMP guidelines
•Basic writing and math skills
•Strong verbal communication skills
•Fluent in English, Spanish a plus
•Must be able to lift 50 lbs.
•Must be able to stand on feet all day

POSITION RESPONSIBILITIES:

  • Perform hourly quality checks of work-in-progress (WIP) and finished goods packaging according to company pre-defined attributes
  • Maintain outgoing packaging quality levels and assures compliance of cGMP’s
  • Verify lot number and expiration dates of finished packaging against the Certificate of Analysis and pick slip
  • Perform verification that the packaging line clearance was properly carried out and releases the packaging line to Production
  • Sign-off that the packaging line was properly prepared by annotation the Equipment Use and Cleaning Log
  • Make certain all pertinent information and required signatures are present on various Batch Record forms
  • Pull and record “beginning”, “middle” and “end” packaging line retention samples
  • Make certain all required documents are present in the Batch Record
  • Perform kit inspection of staged components waiting to be packaged only as required
  • Perform accuracy checks of the weigh scales, in-line scales, and leak detection equipment as needed
  • Perform cap torque measurements as required
  • Verify packaging specifications for customer packaging requirements
South Carolina

Sr Compounder – Piedmont, SC

JOB QUALIFICATIONS:

· Bachelor or Associates degree in science, math, preferred. HS degree with applicable experience acceptable
· Excellent communication, mathematical and writing skills are needed
· Attention to detail and ability to focus is a must
· Must be able to read and follow written directions
· Forklift certification needed (certification provider by PL Developments)
· Willing to work OT and weekends and be flexible with shifts 1/2/Wknd
· A minimum of 3 years of experience in CLN Compounding
· Able to lift up to 50 lbs

POSITION RESPONSIBILITIES:

· Ability to follow compound formulations.
· Need to be detail oriented in order to log, record and complete batch record documents.
· Must be able to learn and set up GD pouch filling machine, operate PLC/HMI interface and changeover/clean intricate pieces of the assembly
· Ability to understand specifications to determine batch characteristics, type and weight of ingredients to be used.
· Able to select, pre-weigh ingredients to specification and to reconcile ingredient usage for each batch.
· Must be able to operate critical equipment, valves, pumps etc. to be able to mix and compound batches to formula.
· Must be able to wash and sanitize mixing tanks and other equipment, as necessary.
· Must be able to handle multiple tasks with minimal supervision.
· Must be able to navigate and perform transactions throughout the Oracle inventory system.

PHYSICAL REQUIREMENTS:

  • Walking, standing, stooping and bending for long periods of time.
  • Must be able to pick up 50 lbs.
  • Must be able to understand HMI operation
  • Must be able to work both in climate controlled and outdoor environments.
  • Comfortable with exposure to confined areas and chemicals.
  • Must be able to work in a fast paced production environment

QA Label Room Inspector – Piedmont, SC

JOB QUALIFICATIONS:

· Computer literate in Microsoft Windows and Microsoft Office
· Knowledge of FDA/cGMP guidelines preferred
· Basic writing and math skills required
· Strong verbal communication skills
· Must be able to lift 50 lbs.
· Must be able to stand on feet all day

POSITION RESPONSIBILITIES:

· Pull labels and inserts as indicated on the Work Order
· Stage picked labels and inserts
· Generate bar code labels for work order as required
· Service the supply window and physically issue labels, inserts, etc. for Packaging lines; accept printed material returns from the Packaging lines
· Keep track of labeling inventory
· Maintain Reject and Destruction Binder and update the Excel spreadsheet
· Maintain log of printed material distribution
· Prepare NCMRs for rejected material as needed
· Perform any additional tasks assigned by Supervisor or Manager
· Perform investigation on printed materials when a variance occurs as required

 

Production Reconciliation (GMP Environment) – Piedmont, SC

JOB QUALIFICATIONS:

· Basic Microsoft Word and Excel experience required
· Basic computer skills required
· Knowledge of Oracle a plus
· Math and weight measurement proficiency preferred

POSITION RESPONSIBILITIES:

· Record WIP completions after each skid is prepared, through Warehouse Management System and print the corresponding LPN labels for each pallet
· Makes sure all returned components are properly counted, labeled (LPN) and returned to the warehouse
· Coordinates the close-out of each job when the last skid is prepared
· Verifies the batch folder of each finished job from production lines and confirms that information is properly recorded and the documents are in order according to SOP000178
· Weighs bulk waste for each run and records this and other information pertaining to packaging components in the appropriate batch folder
· Records information from the Shift Production Report for the production lines including hours worked, staff used and units produced in Oracle
· Records in Oracle samples, returns and waste for each batch record folder and print reconciliation reports
· Coordinates investigations with the batch reconciliation group whenever discrepancies appear in the batch reconciliation process

 

Mechanic (Manufacturing/Packaging) – Piedmont, SC

Qualifications:

  • Must have a minimum of 5 years experience in the cosmetics, food or pharmaceutical industry.
  • Must focus on maintenance manager expectations, prevent problems and strive towards continuous improvement
  • Excellent written and verbal communication skills
  • Able to work with minimal supervision
  • Must have own tools
  • Must be able to work any shift and overtime
  • Must be able to lift up to 60lbs

Responsibilities:

  • General maintenance duties such as replacing valves and pumps, motors, gear reducers.
  • Experience with equipment packaging equipment (labelers, rotary and in-line filler, in-line cappers, jet printers, cartoner’s, bundlers, sleevers, heat tunnels and case sealers)
  • Disassembly and assembly of electric motors, pumps, hydraulic and pneumatic systems
  • Repair machinery and conveyor belts
  • Basic electrical knowledge
  • Maintains technical and professional knowledge
  • Perform miscellaneous duties as required for plant maintenance
  • Basic machinist experience using lathe and mill is a plus

 

Warehouse Operator – Duncan, SC

Qualifications:

  • High School Diploma or GED
  • 2-5 years warehouse experience
  • Must be able to operate a sit-down forklift, stand-up forklift and rider jack.
  • Basic Math and computer skills
  • Must be able to lift 80 lbs.
  • Able to work independently

Job Responsibilities:

  • Move, load and unload raw material, components, equipment or finished goods within PLD grounds.
  • Palletize and/or restack finished good cases, raw material or components.
  • Check outbound orders for accuracy and completeness
  • Follow loading and unloading procedures.
  • Weekly check-up and maintenance of forklift equipment
  • Maintain warehouse standards, including housekeeping.
  • Ability to handle multiple tasks as assigned
  • Follow safety regulations and support regulatory requirements
  • Other tasks assigned by immediate supervisor as trained and instructed.
Florida

Granulation & Blending Operator – Miami, FL

JOB QUALIFICATIONS:

  • Associate degree or High School graduated or GED equivalent
  • Minimum three (3) year of work experience in a Pharmaceutical/GMP manufacturing environment
  • Two Year experience on Granulation or Fluid Bed Dryer
  • Demonstrated ability to follow written instructions precisely and perform basic math calculations is required
  • Demonstrated proficiency in the English Language both written and oral
  • Understanding/knowledge of cGMP, safety criteria and the quick learner
  • Adhere to pre-established manufacturing policies, SOP’s, Batch Record Instructions
  • Availability to work extended shift hours on a short time notice
  • Team work oriented
  • Computer literate

POSITION RESPONSIBILITIES:

  • Operate, Clean and/or Troubleshoot manufacturing equipment such as but not limited to Sifter, Granulator, Fluid Bed Dryer, Fitz Mill, Blender and/or Comil
  • Perform and document equipment and manufacturing room cleaning procedures as per SOP
  • Disassemble, Assemble and Set up manufacturing equipment as per Standard Operating Procedures and/or Batch Record Instructions
  • Inspect and/or evaluate equipment for wear and tear
  • Perform minor equipment trouble shooting. Report to Production Supervisor or Manager major equipment repairs
  • Maintain equipment parts and supplies in proper condition
  • Perform as necessary equipment adjustments to maintain batch record specifications during manufacturing process
  • Document cleaning and set up procedures and manufacturing process data, in log book and batch record instructions and/or other pertinent documents
  • Monitor equipment performance to determine any malfunctions
  • Perform In Process Sampling according to manufacturing instructions and recorded in proper documents
  • Maintain equipment and working area on organize and clean conditions at all times
  • Verify all official documentation for completion and accuracy
  • Complete required tasks related to the operation of the assigned manufacturing area
  • Follow company policies, cGMP’s and Standard Operating Procedures

PHYSICAL REQUIREMENTS:

  • Work in a manufacturing environment
  • Able to wear PAPR apparatus. Frequent exposure to dust, noise and fumes
  • Frequent exposure moderate noise levels
  • Lift up to 50 pounds on regular basis. Occasionally lift /move up to 75 pounds
  • Frequent sitting, bending, lifting and walking
  • Stand and/or walk short distances long period of time

Compression Operator – Miami, FL

JOB QUALIFICATIONS:
•High School diploma or equivalent
•5 years experience as solid dose Manufacturing Operator
•Demonstrated proficiency in the English Language, both written and oral
•Proficiency in basic math
•Ability to lift routinely 30-50 pounds
•Physical ability to repetitively lift, stand, climb, bend, etc
•Exposure to vitamins, mineral, herbal, and OTC products disagreeable odors, high-noise levels, continuous standing. No allergies
•Adhere to pre-established manufacturing schedule
•Under minimal supervision, perform manufacturing tasks as assigned in the Manufacturing Department, with proficiency in all aspects of compression

POSITION RESPONSIBILITIES:
•Operate and clean manufacturing encapsulation and/or room and equipment
•Transport blended materials from staging area to encapsulation and/or compression room
•Verify all blend materials for accuracy and quantities received
•Operate encapsulation and/or tablet press machines as per product batch record following Standard Operating Procedures
•Document all process readings in the manufacturing batch record
•Perform changeover and set-up of designated manufacturing equipment
•Practice Good Manufacturing procedure as trained in cGMP training
•Required to wear appropriate safety equipment and adhere to safety procedures and Federal and State regulations
•Monitor tablet press operation periodically and report any abnormal conditions to the immediate Supervisor
•Assist manufacturing supervisor in the collection of information to conduct investigations
•Follow procedures described in SOP’s and report deviations to the immediate supervisor
•Facilitate and cooperate with any Continuous Improvement Program
•Perform other duties as assigned by supervisor

 

Encapsulation Operator – Miami, FL

JOB QUALIFICATIONS:

  • 5+ years experience as solid dose Manufacturing Operator
  • Demonstrated proficiency in the English Language, both written and oral
  • Proficiency in basic math
  • Ability to lift routinely 30-50 pounds
  • Physical ability to repetitively lift, stand, climb, bend, etc
  • Exposure to vitamins, mineral, herbal, and OTC products disagreeable odors, high-noise levels, continuous standing. No allergies
  • Adhere to pre-established manufacturing schedule
  • Under minimal supervision, perform manufacturing tasks as assigned in the Manufacturing Department, with proficiency in all aspects of tablet coating

POSITION RESPONSIBILITIES:

  • Operate and clean manufacturing encapsulation room and equipment
  • Set up encapsulation equipment according to batch record specifications
  • Transport blend materials from staging area to encapsulation room. Verify all containers for accuracy and quantities received
  • Operate encapsulation machines as per product batch record following Standard Operating Procedures
  • Maintain required capsule weight and document all in process quality checks
  • Load the capsules and blend materials into the encapsulator
  • Set up the encapsulator according to the validated parameters
  • Monitor validated encapsulation parameters and make adjustment as needed
  • Transport filled capsule to staging area
  • Document all process readings in the manufacturing batch record
  • Perform changeover and set-up of designated manufacturing equipment
  • Practice Good Manufacturing procedure as trained in cGMP training
  • Required to wear appropriate safety equipment and adhere to safety procedures and Federal and State regulations.
  • Monitor encapsulation machine operation periodically and report any abnormal conditions to the immediate Supervisor
  • Assist manufacturing supervisor in the collection of information to conduct investigations
  • Follow procedures described in SOP’s (Q.C. and MFG.) and report deviations to the immediate supervisor
  • Facilitate and cooperate with any Continuous Improvement Program
  • Perform other duties as assigned by supervisor

Coating Operator – Miami, FL

JOB QUALIFICATIONS:
• High School diploma or equivalent.
• 5-7 years experience as solid dose Manufacturing Operator.
• Demonstrated proficiency in the English Language, both written and oral.
• Proficiency in basic math.
• Ability to lift routinely 30-60 lbs.
• Exposure to vitamins, mineral, herbal, and OTC products disagreeable odors, high-noise levels, continuous standing. No allergies.
• Adhere to pre-established manufacturing schedule.

POSITION RESPONSIBILITIES:

• Perform manufacturing tasks as assigned in the manufacturing department with proficiency in all aspects of tablet coating.
• Operate and clean manufacturing coating room and equipment.
• Operate and clean all coating and solution preparation equipment used in the film coating operation.
• Set up coating equipment and calibrate spray guns.
• Transport core tablets from staging area to coating room. Verify all core tablet containers for accuracy and quantities received.
• Operate tablet coating machines as per product batch record following Standard Operating Procedures.
• Calculate tablet weight gain and document all in process quality checks.
• Load the tablet coater with tablet cores.
• Set up the coaters Compu-Coat system according to the validated coating parameters.
• Monitor validated coating parameters make adjustment as needed.
• Unload coated tablets into container for weight out.
• Calculate and document USP water and colorant weight in the batch record.N
• Transport solution to coating room.
• Document all process readings in the manufacturing batch record.
• Perform changeover and set-up of designated manufacturing equipment.
• Practice Good Manufacturing procedure as trained in cGMP training.
• Required to wear appropriate safety equipment and adhere to safety procedures and Federal and State regulations.
• Monitor coating machine operation periodically and report any abnormal conditions to the immediate Supervisor.
• Assist manufacturing supervisor in the collection of information to conduct investigations.
• Follow procedures described in SOP’s and report deviations to the immediate supervisor.
• Facilitate and cooperate with any Continuous Improvement Program.
• Perform other duties as assigned by supervisor.

California

Health & Safety Specialist – Lynwood, CA

JOB QUALIFICATIONS:

· Minimum of 3 years in the packaging / manufacturing industry
· Bachelor’s degree preferred
· Experience in handling OSHA and other safety related regulatory matters.
· 30 hour General Industry Certification
· Ability to make presentations to various groups and customers
· Computer literate with advanced skills in Microsoft Excel, PowerPoint, and Outlook, working knowledge of Oracle and Agile preferred
· Must be comfortable taking initiative and working across teams and functions
· Must have the ability to work with minimum supervision
· Experience working in a fast paced environment with good time management skills and the ability to maintain and meet deadlines
· Must exercise good judgment, act calmly in emergency situations and maintain strict confidentiality in all matters
· Ability and willingness to work additional hours as necessary for special project deadlines

 

POSITION RESPONSIBILITIES:

· Develop and implement Health & Safety Programs ensuring compliance with company, local and federal government standards in a proactive fashion.
· Review of safety and health program and identify needs and/or changes to existing programs.
· Serve as the primary contact of the Health and Safety Committee; participate in monthly meetings and regularly perform safety walk-through to identify and correct potential safety issues
· Investigate accidents and near misses to determine the causes and the corrective actions necessary to prevent recurrences
· Collect and analyze injury data to identify trends and recommend improvements
· Collaborate with department managers to improve safety performance by continuously increasing a level of awareness and improving safety systems
· Manage and administer worker’s compensation matters, partner with HR on return to work and accommodations where applicable
· Manage, administer and work with the uniform vendor(s) to ensure proper garmenting processes for the facility .
· Maintain records in a confidential manner
· Conduct risk assessments and job hazard analyses and PPE usage
· Monitor emergency response systems to ensure that they are functioning properly
· Provide daily supervision, training and complete evaluations of direct reports
· Responsible for planning, developing and implementing emergency response planning and CPR/AED certification
· Manage support services such as security personnel, parking, facility planning, pest control, uniform management, etc.
· Review monthly facility related bills and assist with the budgeting of the maintenance dept including capital budgets, expenses, facility costs, etc.
· Serve as a project coordinator and effectively communicate with other departments for facility related improvements / projects.
· Develop and maintain good relationships with outside contacts so that all projects and issues are handled effectively and efficiently.
· Manage waste disposal and recycling initiatives to ensure environmental compliance
· Train departments on safe and proper use of equipment and chemicals and facility related tasks
· Monitor partnerships and reparations with landlords
· Update Operations, Facility Management and Safety SOPs and Work Instructions as necessary
· Lead efforts to identify and eliminate hazards at the facility level. Ensure that best housekeeping practices are performed
· Monitor the work of outside contractors, manage projects, review and approve tasks and paperwork submitted and ensure activities are completed on time and correctly
· Schedule, coordinate, and supervise all personnel to ensure safe best practices and clean work environments for the facilities

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