Quality Compliance (Technician) 2nd Shift (2:30pm-11:00pm)
Quality Compliance manager
The QA technician ensures compliance with cGMP and internal policies, procedures and specifications. This position is responsible for performing inspections, batch record review, and quality system functions in accordance with cGMP and related company SOP’s, state, federal and local laws as applicable.
- Manage and maintain company document control and archival systems (hardcopy and electronic) in compliance with internal procedures and policies as well as regulatory requirements.
- Collaborate with team members and site customers to ensure timely deliverables for documentation.
- Track controlled documents through the issuance of Document Control numbers, logbooks, change requests, and document status reports.
- Management of quality documentation which includes but is not limited to number issuance, logbooks and spreadsheets.
- Review of batch records and equipment logbooks.
- Issue batch records, SOP’s. and protocols as needed.
- Assist in scanning of documents as needed.
- Collect purified water and environmental samples and trend results.
- Perform weekly floor audits for manufacturing.
- Perform swab sampling or cleaning validation and or verification.
- Ability to be flexible with working hours and weekend coverage when needed.
- Any other activity as assigned by the Supervisor.
- A college Degree preferably in sciences (i.e., Biology, Chemistry etc.)
- At least two (2 years) to three (3) years of experience in a quality assurance role in a cGMP-regulated environment.