1st and 2nd shift opportunities available 6am-4:30pm and 10am - 8:30pm M-F
The Quality Assurance Manufacturing Services (QAMS)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.Essential Duties:
- 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 QAMS Supervisor immediately.
- Inspect manufacturing floor and equipment every morning prior to starting production to ensure full compliance with BPR, SOP's and 21CFR111.
- Report any violation (spilled materials, errors in weight measurements, etc.) of the Batch Production Records, Standard Operating Procedures and 21CFR111 to QAMS Supervisor 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 testing.
- Complete sampling and inspection documentation per associated SOP's.
- Complete required documentation for deviations as needed.
- Wear personal protective equipment such as (lab coat, gloves, hair net, respirator, etc.) as needed to perform tasks.
- Other duties as assigned.
- HS Diploma/GED College degree or some college work highly desirable.
- Able to read, write and understand English to follow instructions, safety regulations and complete and maintain accurate and organized records.
- Excellent Mathematical skills.
- Excellent Documentation skills.
- Familiar with sample collection processes a big plus
- Knowledge of manufacturing hygiene and proper cleaning standards.
- Excellent attention to detail and accuracy.
- Effective written and verbal communication skills.
- Proficiency with PC computers including Microsoft Office Word, Excel.
- QA experience in Manufacturing big plus
Associated topics: process, prevention, quality, quality assurance analyst, software quality, software quality assurance, software quality assurance engineer, test, test engineer, tester