Quality Control Scientist
Proclinical is currently recruiting for a Quality Control Scientist with a pharmaceutical company located in Boston, MA.
- Represent Quality Control in a highly matrixed, cross functional environment
- Support establishment of Quality Control systems to support commercialization activities
- Support the stability program through tracking of stability pulls, internal data summaries, and preparing data for statistical and preparing data for statistical analysis.
- Support activities to streamline data review, stability data reporting, stability protocols and reports across external labs.
- Review / approve method validation protocols, reports, as applicable for INT, DS and DP
- Data review for CTM batch release (including API, drug product data review).
- Work with internal stakeholders, including QA and Technical Operations, to ensure timely sharing of information and seek out input from these stakeholders as required.
- Provide support for OOS/OOT investigations, as required.
- Reviewing and writing CMC sections to support regulatory submissions.
Skills and Requirements:
- A BS Degree in Chemistry, Biochemistry, Biology or a related discipline with 7+ years of relevant industry experience
- Experience in a GMP laboratory including QC drug substance and drug product stability, preferably small molecule experience
- Experience in OOS/OOT resolution, root cause analysis tools, and monitoring effectiveness of CAPAs Good working knowledge of ICH stability guidelines
- Experience with analytical testing techniques including HPLC, GC, KF, dissolution
If you are having difficulty in applying or if you have any questions, please contact Bri Copeland at 267-297-3280.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.