Quality Control Scientist

Highly Competitive Salary
  1. Permanent
  2. Analytical Chemistry, Biochemistry, Pharmacology
  3. United States
Boston, USA
Posting date: 11 Jan 2021

Proclinical is currently recruiting for a Quality Control Scientist with a pharmaceutical company located in Boston, MA.

Job Description:

  • 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.