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.

Requirements

• 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.

Benefits

• 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.