What are the responsibilities and job description for the QA Specialist position at Havix Group LLC?
If you are looking for a dynamic, innovative, growing company in the pharmaceutical industry that is committed to excellence and integrity, then consider Aavis Pharmaceuticals. We currently have an exciting opportunity available for a QA Specialist. The QA Specialist will Perform manufacturing oversight activities to ensure compliance with policies and procedures. Oversight activities include, but are not limited to, real-time manufacturing batch record review, review of manufacturing documentation (logs, charts, etc.), and resolution of issues on the manufacturing floor.
Job Details:
- Possess and understanding of processes such as Quality Systems (e.g., Deviations, Corrective and Preventive Action reports {CAPAs}, Change Controls, and Out of Specifications {OOSs}).
- Perform Quality Assurance review and approval of Deviation Reports.
- Possess an understanding cGMP and regulatory compliance as defined in government regulations such as 21 CFR Parts 11, 210, 211 , and 600
- Perform oversight and inspections of active production areas to resolve problems and to ensure compliance with SOPs and policies.
- Perform general oversight of Buildings and their associated activities, as required.
- Review and release documents to manufacturing.
- Review all manufacturing support documentation (logbooks, log sheets, charts, etc.)
- Review and release of raw materials.
- Perform audits.
- Write, review, and revise QA SOPs.
- Review SOPs and documents from other departments and provide feedback as necessary.
- Work with other departments to assess if Deviations, CAPAs, and Change Controls are required.
- Assist with training of new employees.
- Coordinate and perform any additional activities or projects assigned by QA Management.
Job Requirements:
Bachelors Degree in Science
Masters Degree in Science preferred but can be offset by experience.
2-5 years experience in pharmaceutical or biotechnology industry or other related industry.
Employment Type
Full-time
WHY SHOULD YOU WORK WITH AAVIS?
Competitive Pay
Medical, Vision, Dental insurance benefits
Lots of Free Merch (Apparel, stationery mugs, tumblers, totes, etc )
401k Benefits with 4% company match
Front Loaded PTO Days
Company wide recreational events
Free snacks
Paid Maternity/Paternity leaves
Amazing Advancement opportunities
So much more...