Biologics Quality Control Specialist
4 days ago
We are seeking a skilled Biologics Quality Control Specialist to join our dynamic team at AGC Inc.
The ideal candidate will have an MSc or PhD degree in Pharmacy, Biotechnology, Biology, Chemistry, or similar, preferably with work experience within Quality Control and/or Quality Assurance and/or Material Management.
In addition, we expect you to bring some of the following experience and characteristics:
- Profound writing and reviewing skills of cGMP documents: raw material specifications, test methods, general procedures.
- Experience setting specifications for compendial and non-compendial raw materials.
- In-depth understanding of US and European pharmacopoeias.
- Experience handling change controls, deviations, and CAPAs, including root cause investigation, and Laboratory Investigations.
You will be key in implementing new raw materials to support new phase I/II projects as well as planning the Raw Material Qualification and Release Testing program for late-stage projects.
Key Responsibilities
- Author and review raw material specification based on European or US regulatory guidelines as well as adapting to supplier change notifications.
- Deliver scientifically sound and cGMP compliant raw material documents and analytical results.
- Involvement in operating the raw material program, including risk assessments and creating qualification protocol/reports.
- Oversight of sampling, both internal and outsourced testing.
Qualifications and Salary
The salary for this position is around $80,000-$110,000 per year, depending on experience. We offer a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement.
About Us
AGC Inc is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way.
Our Culture
At AGC Inc, we value six core values: Knowledge, Trust, Quality, Ingenuity, Accountability, and Teamwork. Our employees are passionate about what they do and strive to achieve our purpose of bringing hope to life for patients around the globe.
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