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NEW YORK

Drug Safety Specialist – Westbury, NY

JOB QUALIFICATIONS:

· Bachelor’s degree in science or related discipline.

· 2-4 years of pharmaceutical, healthcare or relevant 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:

  • Support timely and accurate Drug Safety reporting for critical daily functions including: AE surveillance, intake, triage, ICSR drafting and submission, QC cycles
  • ICSR drafting, including narrative writing, from available data ( supporting documents, etc.)
  • Support QC investigations and regular site follow-up activities on missing/past due investigation reports
  • Familiarity with and adherence to internal Standard Operation Procedures, work instructions, and reporting plans
  • Prepare status updates, as requested
  • Other duties as assigned (temporary or permanent, based on company needs)
  • Record and monitor consumer complaints and initiate investigations
  • Compile investigation reports as a final response to the customers/consumers
  • Generate a MedWatch report as a result of an adverse event
  • Work with pharmacovigilance service provider to assure compliance with PADER reporting to the FDA (periodic adverse drug event reports)
  • Assist in preparing trending reports

Quality Services Specialist – Westbury, NY

JOB QUALIFICATIONS:

· Bachelor’s degree in Engineering, Science or Quality Related Field

· 2+ years experience in the field

· Knowledge of FDA/cGMP guidelines

· Proficient in Microsoft Office

· Experience in Oracle system preferred

· Must possess exceptional verbal and written communication skills

· Must be detail-oriented

· Excellent planning, time-management, problem-solving, and organizational skills

· Ability to work independently

POSITION RESPONSIBILITIES:

· Acts as a Quality Assurance liaison between PLD and customers

· Provides the technical data for the Private Label customers web databases

· Supports Contract business as needed

· Submits chemical assessment and specification documents to customers through WERCS and customer portals

· Works with PLD sites and external bulk suppliers on information requests related to new item launches

· Supports packaging material qualification activities

· Participate in new product team meetings

· Supports audit activities as needed

 

HR Coordinator – Westbury, NY

JOB QUALIFICATIONS:

· Bilingual (English/Spanish) required

· High school graduate or equivalent required, Associate’s degree preferred

· 2+ years of HR experience or related experience required

· Must be proficient in MS Office applications

· Strong organizational skills

· Accurate and attentive to detail

· Excellent verbal and written communication skills

· Ability to work in a fast-paced environment

· Friendly yet professional demeanor

· Ability to work outside of the core business hours when necessary

· Ability to maintain strict confidentiality, and be sensitive to situations where information must be shared on a ‘need to know’ basis

· Open to travel

POSITION RESPONSIBILITIES:

· Act as a first point of contact for employees and provides support in regards to questions concerning various HR policies and procedures, employee relations issues, and complaints

· Responsible for recruitment of entry level Packaging positions in coordination with the other HR Coordinators

· Assist with recruiting responsibilities such as prescreening resumes, scheduling interviews and conducting reference checks

· Responsible for new hire data entry in HRIS and E-Verify

· Responsible for processing of terminations, including documentionation, exit interviews, and updating databases

· Conduct New Hire and/or Benefits orientation

· Trains end users on HRIS

· Process drug and background screening consent forms

· Coordinate temp-to-hire process for packaging staff as needed

· Submit timesheets for temporary EEs and provide backup for their invoices

· Responsible for FMLA and leaves-of-absence administration

· Maintain access card and photo databases

· Update and maintain signature cards

· Work closely with payroll to ensure that employee changes such as transfers, promotions, new hires, terminations, etc. are processed correctly

· Assist on departmental projects as needed

· Reconcile invoices related to Recruitment

· All other duties as assigned

 

Packaging Mechanic – Westbury, NY

JOB QUALIFICATIONS:

  • 5+ years experience in the field
  • Mechanical Engineering degree a plus
  • Knowledge of cGMP and Safety guidelinesPOSITION RESPONSIBILITIES:
  • Perform daily set-ups, adjustments, and maintenance of the Bottle Packaging Machinery
  • Perform quality changeovers, set-ups, adjustments, repairs, and preventative maintenance of all bottle packaging machinery
  • Perform installation and set-up of new visions systems as required
  • Trouble Shoot PLC and machine circuit boards
  • Assist in IQ/OQ/PQ for new machines / tooling
  • Complete, review, and initiate accurate line set-up sheets
  • Help to maintain proper machine functionality to decrease waste and increase uptime
  • PM’s- Preventative Maintenance Tasks as needed
  • RM’s- perform reactive maintenance when needed
  • Continuous review of machine safety feature functionality

Maintenance Custodian (2nd shift) – Westbury, NY

JOB QUALIFICATIONS:

· Must be able to lift up to 50 pounds

· Must have the ability to operate hand, power and bench tools

· Must be willing to work a flexible schedule and overtime as needed

POSITION RESPONSIBILITIES:

· Responsible for performing custodial duties, minor maintenance and other miscellaneous duties in order to ensure that PLD facilities are maintained in a healthy, safe and sanitary manner

· Empty and clean wastebaskets and containers, remove trash; empty and clean ashtrays

· Handle recycling materials using established practices and procedures

· Clean and sanitize restrooms using established practices and procedures

· Clean, strip, wax and buff hard surface floors

· Perform various maintenance tasks such as replacing light bulbs and repairing/cleaning minor fixtures and bug zappers

· Secure building when facilities are not in use, check for unlocked doors and windows, turn off lights in accordance with established procedures

· Perform outdoor cleaning activities such as removing snow or debris from sidewalks and entrances

· Clean and sanitize loading docks using established practices and procedures

· Spot clean walls, toilet partitions and ceiling vents as per cleaning schedule

· Stock facilities with paper and necessary supplies

· Ensure cleaning materials and supplies are stored in a safe and orderly manner

· Follow instructions regarding the use of chemicals and supplies, use as directed

· Section off unsafe conditions in work area and report any hazardous conditions to supervisor immediately

· Perform painting tasks as necessary (directed by management)

· Work cooperatively with other departments

· Perform other duties and special projects as assigned

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

 

Warehouse Operator – Copiague, NY

JOB QUALIFICATIONS:

  • High School Diploma or GED
  • 2-5 years warehouse experience
  • Must be able to operate a single, deep reach truck, sit down forklift, stock picker, electric jack and scissor lift
  • Basic Math and computer skills
  • Must be able to lift 80 lbs.
  • Able to work independentlyPOSITION RESPONSIBILITIES:
  • Operate a handheld device and forklift to pick and stage orders, perform cycle counts, perform put away transactions and to receive transactions
  • Match product picked to packing slips and/or picked reports for accuracy
  • Operate a forklift in a safe and efficient manner to retrieve or store material
  • Unload/load trucks as necessary
  • Operate a handheld device to store and move material properly around warehouse
  • Produce a high volume of work and rarely makes errors
  • Operate a handheld to perform miscellaneous transactions such as packing, unpacking, RMA’s, WIP Returns, organization transfers, sub transfers, pick samples and replenishments
  • Use computer to do inventory inquiries, que tasks and run inventory reports
  • Ability to check both sales orders and work orders
  • Report damage of product, storage racks or any unsafe condition to management immediately
  • Verify safety inspection sheet has been completed before operating a forklift
South Carolina

Validation Engineer – Piedmont, SC

• Establish validation standards, develop testing protocols, prepare equipment, document test results and maintain records for later analysis • Validate new and re-validate as appropriate existing equipment used in OTC/Rx manufacturing, packaging, compose reports and make adjustments to equipment or processes that require improvement
• Evaluate, implement and monitor processes, operating systems, critical utilities, manufacturing and packaging equipment in accordance with appropriate regulatory agency validation requirement and current industry practices • Create/edit/maintain necessary documentation that pertain to the Evaluation of the Process Qualification PPQ/Manufacturing & Packaging Equipment Qualification and the Status of the Critical Utilities (HVAC, USP DI Water Compress Air System) as well as any other utilities that affect directly the Critical Products Attributes • Evaluation of the Critical Utilities, Manufacturing and Packaging Equipments calibration and maintenance monitoring during the execution of these systems Qualification • Evaluation of existing and/or creation of Cleaning, Operation Procedures for the critical utilities, manufacturing and packaging equipments. Dominated all the theory involve in all PLD and Avema Cleaning Validation Programs (Sites)
• Assess the availability of raw materials and their impact in a specific manufacturing process not only from the process influence but also from the safety and environmental influence of the facility related to this material
• Support the conversion during the “Scale Up” of any Manufacturing Process that has been developed at a small-scale process into commercially viable large-scale commercial operations
• Coordinate and responsible of all New Molecules transfers from R&D bench/pilot size to the manufacturing.
• Monitor and improve the efficiency, output and safety of manufacturing processes through observations and measurements as well as by collecting and interpreting data from other technical and operating personnel
• Coordinate projects directly with vendors and service providers to ensure that all validation and installation requirements are being satisfied during the execution of protocols
• Work closely with other specialists (including scientists) for quality control of raw materials.
• Measure instrument or software performance to determine if tools are performing as described for temperature mapping, and calibration activities
• Provide validation support for Computerized Systems including Automation and Laboratory Equipment and qualification / validation activities of Primary / Secondary manufacturing operations
• All other duties, as assigned

 

QC Receiving Inspector – Duncan, SC

JOB QUALIFICATIONS:

  • High School Diploma required
  • 2-5 years of experience in related field
  • Knowledge of FDA/cGMP guidelines, 21 CFR Parts 111, 210 & 211 preferred
  • Highly Organized and strong attention to detail
  • Time management skills and ability to handle multiple tasks on time
  • Excellent oral and written communication skills in English
  • Proficient in Word, Excel, Power Point and Visio
  • Understanding of Root Cause Analysis, Investigation and CAPA
  • Working knowledge of Oracle and Agile
  • Experience with Warehouse Management System (WMS)
  • Must be able to lift up to 50 lbsPOSITION RESPONSIBILITIES:
  • Manage receiving inspection of all Critical components, Sub-assembly and FG
  • Manage and support JIT program
  • Review and report all documentation from shipments prior to release in Oracle
  • Print and review Data Loggers (Temp Tales) from shipments
  • Report, document, investigate and disposition shipping temperature monitoring excursions.
  • Manage NCMR and RMA programs and oversee trailer loading or products slated for destruction
  • Manage physical inventory in NCMR and Quality Cages
  • Write and Review CRNs/NCMRs/CAPA/Investigations/Deviations as needed
  • Perform and manage annual review of Finished Good retains
  • RMA inspection & disposition
  • Generate reports to look for trends in inspections
  • Suggest solutions to management for trends when required
  • Work with cross-functional departments to mitigate trends
  • QA inquiries from other sites or vendors
  • Oversee on-site reworks
  • Train the team on processes as needed
  • Assist Quality Management as needed

 

Maintenance Manager – Piedmont, SC

JOB QUALIFICATIONS:

  • 7-10 year’s progressive experience in manufacturing environment, machine maintenance and repair
  • Supervisory experience required.
  • An AA degree in mechanical, electrical, or industrial engineering a plus;
  • Must be highly motivated and able to work independently.
  • Excellent written and verbal communication skills
  • Ability to work with minimal supervision
  • Proven track record of reducing costs through processes and efficiencies
  • Experience in tool design and modifications [CB1]
  • Outstanding verbal and written communication skills
  • Hands-on, team oriented and committed to business improvement processes
  • Process-oriented mentality
  • Strong problem solving capabilities
  • Strong supervisory skills
  • Ability to manage multiple priorities
  • Knowledge of OSHA, cGMP, and FDA guidelines

POSITION RESPONSIBILITIES:

  • Coordinates activities of workers engaged in daily production line set-up of machinery and equipment.
  • Analyze and design effective systems and tools to optimize use of space, equipment, material and personnel
  • Directs and or assist workers in electrical, electronic, mechanical, and repair of machinery and equipment.
  • Plans and issues work schedules to ensure continual safe and efficient operation of a line production facility
  • Works with GM/Site Leader and Dir of Maint./Eng. to coordinate maintenance work tasks and follow a Department Maintenance Plan
  • Works closely with quality assurance and maintenance personnel to prevent problems with products and process issues.
  • Responds to unplanned operational or maintenance events
  • Coordinates on-the-job training for line mechanics and facilities mechanics
  • Ensure all manufacturing safety regulatory policies and procedures are implemented and maintained at all times
  • Support all current and new line process introductions
  • Manage and assist with CMMS to insure PM’s and Workorders are up todate.
  • Promotes team involvement and participation in setting goals, priorities, and strategies for safe, efficient, and effective plant/facility operations
  • Works with the team to establish goals, priorities, and expectations, and to develop the action plans and strategies for accomplishing them
  • Conducts employee performance evaluations
  • Review daily mechanical activities to assure compliance with company cGMP’s, and SOP’s
  • Ensure that each member of the mechanical team is properly trained along with documentation indicating training information
  • Demonstrates continuous effort to improve operations, decrease turnaround times, streamline work processes, and work cooperatively and jointly to provide quality seamless customer service.
  • Determine and eliminate root causes and diminish occurrences in the line production process to reduce downtime.
  • All other duties, as assigned

Physical Requirements:

  • Work performed in factory settings
  • Exposure to shop environment such as noise and dust
  • Occasionally required to lift up to 20 lbs
  • Must be able to work any shift and overtime

 

Manufacturing Operations Supervisor (2nd Shift) – Piedmont, SC

Responsibilities:

  • Coordinate shift production plan (schedule) for lines under his/her responsibility and make changes to the team staff as necessary to support operational goals
  • Train or arrange training for direct reports in all applicable new and revised Standard Operating Procedures (SOP’s)
  • Coordinate with Packaging Supervisors to communicate issues related to components and supply requirements
  • Supervise all packaging areas to ensure that each line starts and stops at the appropriate time and is running according to safety guidelines
  • Keep in constant communication with QC/QA personnel to discuss in-process quality level and specifications
  • Monitor lines and line leaders in attaining target shift output
  • Partner with QC, Mechanics, and Industrial Engineers to explore enhancements in procedures and practices aimed at improving efficiencies and costs
  • Create and investigate operational deviations and determine RC/CAPA’s with implementation strategies.
  • Report all critical and major safety and quality issues to Plant Manager and VP of Operations and EH&S representative
  • All other duties as assigned

Job Qualifications:

  • High School Diploma required, Associate or Bachelor’s degree preferred
  • Demonstrated 2nd or 3rd shift operational success
  • At least 3 years relevant experience on off shift schedule
  • Must possess exceptional verbal and written communication skills
  • Strong problem-solving skills
  • Proficient in MS Office (Word and Excel)
  • Ability to clearly communicate shift goals and manage operational activities for successful attainment

 

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



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

Compounder – Lynwood, CA

JOB QUALIFICATIONS:

• High School graduate required or equivalent

• Excellent communication, mathematical and writing skills are needed

• Must be able to read and follow written directions in English

• Forklift certification needed (certification provider by PLDevelopments.)

• Willing to work OT and weekends and be flexible with shifts 1/2/3

• A minimum of 5 years of experience

• Able to lift up to 50 lbs

POSITION RESPONSIBILITIES:

• Ability to follow formula critical instruction and batch OTC (over the counter)

Products.

• Need to be Detailed oriented enough to log, record and complete batch record keeping documents.

• The ability to be able to navigate and perform transactions throughout the Oracle inventory system.

• 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.

• Understanding of adjustments to temperature, time, and speed controls required by (CF) compounding formula. To be able to blend ingredients, adding additional ingredients during blending cycle as specified on (CF) compounding formula.

• Must be able record and document quantity of materials used.

• Be familiar with the processes of the department, to ensure transfer of product to holding tanks.

• Must be able to wash and sanitize mixing tanks and other equipment as necessary.

• Must be able to handle multiple tasks with minimal supervision.

Able to work inter-departmentally in an effective manner to carry out daily duties manner to carry out daily duties.

 

Line Mechanic – Lynwood, CA

Function:

Repair mechanical systems in basic shop atmosphere to ensure proper, safe and efficient operations within the Production and other areas of the facility. Installs new or modifies existing equipment/systems as necessary, installs specialized equipment. Electrical Proficiency required. An employee in this position works an environment in which safety, environmental and health concerns may demand constant attention.

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
  • Bilingual English/Spanish helpful but not mandatory
  • Must be able to work any shift and overtime

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

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