Sr. Quality Assurance Associate
On-site · Alpharetta, Georgia, United States
Job Summary
Quality Assurance Associate role supporting multiple QA areas in a pharmaceutical/FDA-regulated environment. Responsibilities include inspecting incoming raw materials and components, performing in-process and finished goods inspections, line clearance, reviewing production records for cGMP compliance, approving product release, ensuring proper usage and disposal of packaging components, initiating deviations and assisting investigations, assembling data for APRs and reports, reviewing logs and environmental monitoring, calibrations, developing QA procedures with management, providing data for recalls and complaints, preparing metrics for Quality Council, maintaining vendor quality agreements and supplier list, documenting investigations, participating in internal audits, creating and maintaining master documents, issuing and tracking change controls, entering training in MasterControl, maintaining GMP training records, and ensuring regulatory compliance with SOPs and pharmacovigilance guidelines. Must have strong proficiency with Microsoft Office, MasterControl, and effective communication skills. Fluent in English and able to work independently within documented procedures and as part of a team.
Required Qualifications
- Minimum of a 2-year degree or certification in a technical program; a Bachelor’s degree in a scientific or technical field, preferred.
- 2 years of experience in a cGMP environment, preferred.
- Prior quality assurance experience in an FDA regulated industry and working knowledge of quality systems (cGMP) and regulatory requirements (21CFR, Parts 11, 210 and 211) preferred.
- Basic competence with medical and therapeutic terminology.
- Knowledge of statistics, preferred.
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