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The Quality Control Operations (QCO) Analyst II Contractor supports maintaining high standards of quality and compliance from development through commercialization. The role includes performing routine and non-routine testing, participating in data trending, investigations, and lab operations, and supporting method transfers, qualification/validation, verification, and implementation. This position enhances QC efficiency and effectiveness.
Key Responsibilities:
- Perform routine/non-routine analytical (HPLC/UPLC) and/or microbiological assays for raw materials, in-process samples, product release, and stability studies following SOPs.
- Support weekend lab operations and maintain training records.
- Assist in lab equipment and inventory maintenance, including reagent and sample prep.
- Review data timely and qualify as a data reviewer Perform operational assignments (raw material processes, environmental monitoring, in-process testing).
- Contribute to updating controlled documents (SOPs, work instructions, test methods).
- Follow internal policies, SOPs, and regulatory standards (GMP, GLP, ICH) Participate in continuous improvement initiatives and cross-functional collaboration.
- Support regulatory submissions, inspection readiness, and audits.
- B.S. in chemistry, biology, biochemistry, or related field 4-8 years of pharmaceutical/biotech experience in GMP QC or equivalent.
- Experience in method transfer/implementation; understanding of method lifecycle management.
- Strong technical writing, data analysis, problem-solving, and organizational skills.
- Proficiency in LabWare LIMS, Excel, Word, and PowerPoint.
- Contract position with possible extension
- Location: Norton, MA, with occasional responsibilities at other locations.
- Weekend coverage is required.
- First shift, Friday-Monday (4 x 10 hours), with initial Monday-Friday training.
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