Quality Control Analyst II

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 is an onsite role in Norton, MA, with occasional responsibilities at other locations.

Responsibilities

• Perform routine and 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 preparation
• 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 preferred
• Strong technical writing, data analysis, problem-solving, and organizational skills
• Excellent communication and teamwork
• Proficiency in LabWare LIMS, Excel, Word, and PowerPoint preferred

Schedule

• First shift, Friday-Monday (4 x 10 hours), with initial Monday-Friday training
• Weekend coverage is required

Pay

$38–$42/hour based on experience