51 минуту назад
QC Scientist – Compendial & Analytical Quality (Biopharmaceutical)
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
QC Scientist – Compendial & Analytical Quality (Biopharmaceutical): Ensuring pharmaceutical quality control compliance through compendial monitoring, analytical data authorization, controlled-document management, and oversight of external laboratory testing with an accent on pharmacopeial requirements and regulated laboratory practices. Focus on updating SOPs and analytical methods, leading investigations and root cause analyses, and coordinating CRO testing, sample shipments, and outsourced data review.
Location: Fully site-based in Bend, Oregon, United States. Relocation assistance is available for eligible candidates and their families.
Company
operates globally connected sites that manufacture medicines and support the development of life-science therapies.
What you will do
- Evaluate and authorize analytical raw data, laboratory notebooks, and test reports for data integrity and compliance.
- Monitor compendial updates and implement changes required by USP, EP, JP, BP, and other pharmacopeial standards.
- Manage controlled documents, records, material specifications, SOPs, analytical methods, and validation protocols.
- Lead and support laboratory investigations, deviations, and root cause analyses.
- Coordinate external laboratory testing, including CRO timelines, method feasibility, sample shipments, and outsourced data review.
- Coordinate purchase orders for external testing services and laboratory consumables.
Requirements
- Bachelor’s degree in Chemistry, Biology, Biochemistry, or a related scientific field.
- 3–5 years of hands-on experience in a regulated cGMP/GLP pharmaceutical or biopharmaceutical quality control laboratory.
- Strong knowledge of global pharmacopeias and experience verifying and executing monographs for raw materials and finished products.
- Experience coordinating testing with external contract laboratories or CMOs, shipping samples, and reviewing external analytical data.
- Practical experience with HPLC, GC, UV-Vis, FTIR, titration, and basic wet chemistry.
- Technical writing experience for SOPs, protocols, document updates, and data integrity requirements.
Culture & Benefits
- Work in a safe, high-quality cGMP laboratory focused on personal growth and new ideas.
- Day-one life, disability, health, dental, and vision insurance options.
- 401(k) match of 100% up to 6% of salary, plus an automatic company contribution.
- Performance-linked bonus program based on company and individual success.
- In-person collaboration supports technical precision in medicine manufacturing.
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