Quality Assurance Specialist
21 hours ago
Civica Rx is a 501(c)(4) social welfare organization dedicated to reducing chronic generic drug shortages and related high prices in the United States. Our team of experienced healthcare and pharmaceutical industry leaders is committed to ensuring quality generic medications are accessible and affordable to everyone.
The QA Operations Specialist will play a critical role in our newly forming team at the Petersburg, Virginia site, responsible for ensuring the manufacturing and operations activities comply with applicable regulatory standards. This includes reviewing and approving materials, bill of materials, batch records, and GMP documentation to support the design, implementation, and maintenance of manufacturing processes that meet or exceed FDA requirements.
Key responsibilities of this position include:
- Supporting operational compliance aspects of sterile fill-finish manufacturing of products, including material, bill of material, and executed batch record review and approval.
- Partnering with operations to develop manufacturing batch records to be compliant with regulatory and company requirements.
- Working cross-functionally to determine defect criticality, inspection methods, and training plans for both QA Operations and Manufacturing employees.
- Providing cross-functional support to MSAT and Operations in establishing process limits for manufacturing processes such as filling and packaging.
- Acting as a resource for colleagues and leading or participating in Quality Risk Management Processes as needed.
The ideal candidate will have a Bachelor's degree with 4+ years of experience in a QA role in a cGMP production environment, with strong technical expertise and project management skills. Experience in manufacturing batch record design, sterile pharmaceutical isolator technology, combination products, and medical devices is highly desirable.
Civica Rx is committed to delivering high-quality results, working with others to overcome challenges, and focusing on what matters. We continuously look for opportunities to learn, build skills, and share knowledge with others.
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