Quality Control Analyst III

The Quality Control Operations (QCO) Analyst III Contractor plays a crucial role in ensuring quality and compliance across development and commercial programs. This position involves executing routine and non-routine testing, participating in data trending, supporting investigations, and contributing to laboratory operations. Additionally, the Analyst III will assist in method transfers, qualifications, and regulatory documentation, ensuring compliance with industry standards.

Key Responsibilities:

• Perform routine and non-routine analytical and/or microbiological testing for raw materials, in-process samples, product release, and stability studies following established SOPs.
• Support weekend laboratory operations (Analytical, Microbiology, Raw Materials) to ensure continuous schedule adherence.
• Maintain up-to-date training records and adhere to testing schedules, ensuring timely completion of assignments.
• Assist in laboratory equipment maintenance and inventory management, including reagent and sample preparation.
• Conduct timely data review and verification, qualifying as a reviewer for efficient data availability.
• Perform role-specific assignments such as SAP transactions, environmental monitoring, and in-process testing.
• Revise and update controlled documents, including SOPs, work instructions, and test methods, to align with industry and regulatory standards.
• Ensure compliance with GMP, GLP, and ICH guidelines, upholding the highest quality standards.
• Participate in inspection readiness activities and support audits and regulatory inspections as needed.
• Collaborate with CMC Development, Manufacturing, Technical Services, Materials Management, and Quality Assurance to align with business goals.

Top Skills:

• Strong understanding of GMP compliance in a QC laboratory setting.
• Experience with QC Chemistry (HPLC/UPLC, Empower) or QC Microbiology (Bioburden, endotoxin, TOC, conductivity).
• Technical expertise in data review, method validation, and regulatory compliance.
• Ability to support a continuous operational schedule, including weekend coverage.

Qualifications & Experience:

• Education: Bachelor’s degree in Chemistry, Biology, Biochemistry, or a related scientific field.
• Experience: Minimum 4 years in a GMP Quality Control laboratory within the pharmaceutical or biotech industry.
• Experience with method transfer, analytical method implementation, and method lifecycle management.
• Strong technical writing skills, with preference for investigation documentation.
• Proficiency in data analysis and interpretation, ensuring compliance with regulatory requirements.
• Hands-on experience in QC Chemistry (e.g., HPLC/UPLC with Empower software) or QC Microbiology (e.g., Bioburden, endotoxin, conductivity, TOC).
• Strong problem-solving skills and experience conducting investigations and implementing CAPAs.
• Proficiency in LabWare LIMS, Excel, Word, and PowerPoint preferred.

Work Schedule & Location:

• Schedule: Friday - Monday (4 x 10 hours), with initial Monday-Friday training period.
• Location: Primarily Norton, MA, with occasional responsibilities at other locations.
• Onsite Role: 100% onsite presence required.