QA Specialist

Description:

Review manufacturing and packaging batch records for accuracy, completeness, and compliance prior to release Collaborate on corrections or escalate to leadership. Document deviations or work with others to investigate and close. Input change controls, route for approvals, review, and release Assist with other Quality Systems tasks as needed. Work with secondary vendors and suppliers on QA compliance checks.

Skills:

Quality assurance, Gmp, Batch Record Review, Document control, cGMP, Deviation, Auditing

Top Skills Details:

Quality assurance,Gmp,Batch Record Review

Additional Skills & Qualifications:

BS Degree (or substitute 5 years of applicable experience) 2-3 years of pharmaceutical QA operations experience auditing batch records in some capacity Additional QA exposure to manufacturing operations is a plus

Experience Level:

Intermediate Level