Research Associate II, Quality Control
$98,000–$110,000 year
On-siteBedford, Massachusetts, United States
Bedford, Massachusetts, United StatesOn-siteFull Time$98,000–$110,000 yearEntry LevelBachelors DegreeBiopharmaceuticalSmall
Full TimeEntry LevelBachelors DegreeSmallBiopharmaceutical
Job Summary
Execute routine Quality Control testing activities including QC analytical chemistry using HPLC, UPLC, GC, and dissolution instrumentation. Author technical reports, ensure instrument calibration, and troubleshoot equipment issues while coordinating vendor repairs. Participate in method development and validation, data review, and CAPA, change controls, investigations, and deviations. Order laboratory supplies and maintain general laboratory upkeep following Good Documentation Practices and cGMPs. Support external outsourcing of testing and coordinate scheduling for reagents and product samples.
Required Qualifications
- Bachelor's degree in Chemistry or related field
- 2+ years of work experience in a GMP Quality Control environment
- Prior experience with HPLC and UPLC
- Knowledge of safe laboratory practices
- Strong verbal and written communication skills
Desired Qualifications
- Knowledge of CFR 210,211, USP and FDA/ICH guidance is preferred
- Experience with USP App IV dissolution apparatus is preferred
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