Quality Assurance Associate III
About The Position
We are seeking a QA Associate III, In Plant Operations to support GMP manufacturing through review and approval of batch‑related documentation required for product disposition. This includes batch records, analytical results, equipment records, deviations, and change records. The QA Associate III plays a key role on the manufacturing floor, partnering with cross‑functional teams to resolve issues, ensure compliance, and support efficient execution of production activities. You’ll join the Quality Assurance (In Plant) team, responsible for real‑time QA support to manufacturing and batch disposition activities. The team works closely with Manufacturing, QC, and Engineering to ensure GMP compliance, resolve issues on the floor, and maintain operational readiness in a fast‑paced biologics environment.
Requirements
- Strong understanding of biologics manufacturing and quality systems.
- Working knowledge of cGMP, FDA, and ICH requirements.
- Ability to analyze moderately complex issues and support resolution.
- Clear written and verbal communication skills, including explaining compliance decisions.
- Strong organizational skills and attention to detail.
- Ability to work independently and collaboratively.
- Proficiency with Microsoft Office and data systems.
- Bachelor’s degree in Biology, Chemistry, or related field, or equivalent experience.
- 5+ years of QA or related experience in a regulated environment.
- Experience applying GMP regulations in a manufacturing setting.
Nice To Haves
- Experience in biologics manufacturing.
- Experience with batch review and disposition.
Responsibilities
- Review executed Master Production Records (MPRs) and supporting documentation for completeness, accuracy, and GMP compliance.
- Review and approve analytical results, including Certificates of Analysis and in‑process data.
- Support batch disposition by ensuring all required quality inputs are complete and compliant.
- Partner with Manufacturing and cross‑functional teams to resolve documentation errors, deviations, and non‑conformities.
- Serve as QA point‑of‑contact on the plant floor; escalate issues and support timely resolution.
- Review and approve raw material release data for manufacturing use.
- Review and approve preventive maintenance and repair work orders impacting GMP systems.
- Support issuance and control of batch records and related documentation.
- Participate in investigations, change records, and process improvement initiatives.
- Contribute to SOP updates and quality system improvements.
- Support training and qualification activities.
- Provide cross‑shift support as needed.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
