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...