Join Us in Bringing Hope to Life
Our purpose is to bring hope to life by enabling life‑changing therapies for patients around the globe, creating a healthier and happier tomorrow. To advance this purpose, we rely on team members who value excellence, collaboration, and meaningful work. If this resonates with you, we invite you to explore the role further and apply.
Job Summary
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.
About the Quality Assurance Team
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.
Key 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.
Skills
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.
Qualifications & Experience
Required:
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.
Preferred:
Experience in biologics manufacturing.
Experience with batch review and disposition.
Formalities
Location: Bothell, Washington
Schedule: Wednesday–Saturday, 8:00 pm – 6:30 am
Compensation: $74,960 – $103,070
Who We Are
AGC Biologics is a global Contract Development and Manufacturing Organization with a strong presence in the United States. From our headquarters in Bothell, Washington, we develop and manufacture life‑changing advanced biologics for some of the world’s most innovative pharmaceutical companies. Together with our team members across Europe, the U.S., and Japan, we deliver development and manufacturing of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells therapies. Across our global network, we are united by one mission: To work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market.
We are a collaborative, inclusive, and equal‑opportunity organization where team members are valued for their expertise, teamwork, and ingenuity.
Skills Required
- 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
- Working knowledge of cGMP, FDA, and ICH requirements
- Strong understanding of biologics manufacturing and quality systems
- Proficiency with Microsoft Office and data systems
- Experience in biologics manufacturing
- Experience with batch review and disposition
What We Do
AGC Biologics offers deep industry expertise and uniquely customized services for the scale-up and cGMP manufacture of protein-based therapeutics (using mammalian and microbial systems), mRNA, pDNA, viral vector and cell therapy products, from pre-clinical to commercial production, including our proprietary CHEF1TM Expression System for efficient protein production with CHO cells. Our company DNA drives us to provide innovative solutions to partner with our customers in helping them reach their goals and accelerate their projects at our cGMP-compliant facilities in the US, Europe and Japan, as well as to facilitate approval and manage spending during the product lifecycle. We forge exceptionally strong partnerships with our customers and we never lose sight of our commitment to deliver reliable and compliant drug substance. Visit www.agcbio.com to learn more.
