Job Title: Sr. QC Specialist

Work Location: Middlesex County, Massachusetts

Summary:

This position is focused on supporting in-house cGMP manufacturing through laboratory-based Drug Product and Drug Substance testing for release and stability. The role involves routine lab testing, inventory management, data reporting, and collaboration with various departments to ensure quality and compliance in manufacturing and analytical processes.

Responsibilities:

• Conduct routine microbiology testing to support product release and stability requirements.
• Execute testing activities related to assay validation and analytical method verification.
• Review laboratory data, protocols, reports, and address quality events such as deviations and out-of-specification results.
• Draft, review, and update standard operating procedures, protocols, and technical reports.
• Engage in continuous improvement initiatives to enhance laboratory operations and efficiency.
• Collaborate with cross-functional teams to support cGMP manufacturing and process validation efforts.
• Manage laboratory inventory and ensure accurate data reporting in compliance with regulatory standards.
• Contribute to the Quality Control team’s objectives and support group goals through effective teamwork and communication.

Qualifications:

• Bachelor’s degree in a scientific discipline.
• Minimum of 5 years’ experience in a GMP environment and/or Quality Control laboratory.
• Hands-on experience with PCR/qPCR testing and aseptic sampling techniques.
• Proficiency in laboratory skills, organizational abilities, and attention to detail.
• Ability to work independently and collaboratively within a team setting.
• Experience with Quality Management Systems, deviation investigations, out-of-specification (OOS) results, CAPAs, and Change Controls.
• Familiarity with continuous improvement projects and project management skills are advantageous.
• Proficient in Microsoft Outlook, Word, Excel, and laboratory data management systems.
• Knowledge of FDA and EU compliance principles; familiarity with USP and ICH guidance preferred.

Published Category: Quality & Validation