Momentum Specialized Staffing
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at Momentum Specialized Staffing
|Schedule:||Monday - Friday, 10:00pm to 6:30am|
GENERAL DESCRIPTION: The QA Manufacturing Services Technician is responsible for performing daily production audits and inspections of the manufacturing area, as well as collecting in-process and finished product samples to determine the production process meets quality specifications and standards.
- Review Batch Production Records (BPR) and Packaging Records for completeness, accuracy and good documentation practice per associated Standard Operation Procedures (SOP’s).
- Inspect manufacturing area for hygiene and good housekeeping to make sure PPE (hair nets, gloves, respirators, etc.) are being used properly; report any violations and/or concerns to the Director of QA immediately.
- Inspect manufacturing floor and equipment every morning prior to starting production to ensure full compliance with BPR, SOP’s and 21CFR§111.
- Report any violation (spilled materials, errors in weight measurements, etc.) of the Batch Production Records, Standard Operating Procedures and 21CFR§111 to the Director of Quality Management, immediately; complete system incident reports, as needed.
- Collect and measure In-Process samples per BPR sampling protocol as directed by the Lab Manager and SOP’s.
- Collect and measure Finished Product samples from packaging line per Packaging Record sampling protocol or as directed by the Lab Manager and SOP’s.
- Deliver In-Process and Finished Product samples to the Quality Control Laboratory for sampling.
- Complete sampling and inspection documentation per associated SOP’s.
- Complete required documentation for non-conformances and deviations as needed.
- Perform internal audits of the manufacturing facility to assure facility compliance to affiliate, regulatory and best industry quality, GMP, and sanitation standards.
- Wear personal protective equipment such as (lab coat, gloves, hair net, respirator, etc.) as needed to perform tasks.
- Work cooperatively with co-workers and supervisors.
- Maintain regular and punctual attendance at work.
- All other duties as assigned.
MARGINAL JOB FUNCTIONS:
- Perform Raw Material sampling as needed.
- Perform Finished Product final inspection and release prior shipping.
- Standard Operation Procedure development and/or review.
QUALIFICATIONS & SKILLS REQUIRED TO PERFORM JOB DUTIES:
- Able to read, write and understand English to follow instructions, safety regulations and complete and maintain accurate and organized records.
- Mathematical skills.
- Familiar with sample collection processes.
- Knowledge of manufacturing hygiene and proper cleaning standards.
- Extreme attention to detail and accuracy.
- Effective written and verbal communication skills.
- Proficiency with PC computers including Microsoft Office Word, Excel.
- Fine motor skills to accurately measure and collect samples.
- Ability to work with minimum supervision.
PHYSICAL REQUIREMENTS TO PERFORM JOB DUTIES:
- Stand and walk on hard surfaces for long periods of time, up to 4 hours at a time.
- Stand/remain upright and stationary for long periods of time, up to 4 hours at a time.
- Kneel, bend, stoop and squat repetitively.
- Twist and turn repeatedly.
- Reach down, forward and overhead repeatedly.
- Able to see/read details at close range (within a few feet) to detect defects, etc.
- Fine motor skills to use measuring devices (calipers, scales, etc.) with precision and accuracy.
- Use a computer to accurately record information.
- Use personal protective equipment (PPE) and wear gloves, lab coat, hair net and face mask, respirator, etc.
- Push/pull a 2-shelf lab cart or dolly.
- Lift up to 75lbs.
EDUCATION AND/OR EXPERIENCE REQUIRED TO PERFORM JOB DUTIES:
- High school diploma or GED.
- Associates or Bachelor’s degree in quality control management preferred.
- 0-3 years of experience in a regulated industry (i.e. Pharmaceutical, Dietary Supplements, Medical Device or Biopharmaceutical).
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