Job Title: Senior QC Specialist

Work Location: Middlesex County, MA

Summary:

Seeking a Senior QC Specialist to support quality control activities, analytical method development, and cross-functional collaboration in a fast-paced environment. This role is responsible for ensuring the integrity and reliability of analytical methods and materials throughout the product lifecycle, with a focus on continuous improvement and compliance with regulatory standards.

Responsibilities:

• Serve as the primary quality control liaison with development, manufacturing, and regulatory teams to integrate QC requirements into project workflows.
• Lead the optimization and validation of analytical methods for raw materials, intermediates, finished products, and stability samples.
• Establish and monitor method performance metrics, driving ongoing improvements in QC methodologies as product needs evolve.
• Maintain technical expertise in QC analytical platforms, providing troubleshooting and performance monitoring support.
• Manage the stability program for released products and reagents, including protocol development, sample scheduling, data trending, and expiration dating.
• Conduct routine and non-routine QC testing in accordance with SOPs, work instructions, and regulatory guidelines.
• Author and update SOPs, test methods, and work instructions to support QC laboratory operations.
• Analyze QC data to identify trends, flag anomalies, and provide technical guidance on nonconformances, CAPAs, and change controls.

Qualifications:

• Bachelor’s degree in biological, chemical, or physical science, or equivalent experience.
• Minimum 5 years of quality control experience in biotech, pharmaceutical, or molecular diagnostics settings.
• Proven experience leading QC method development and validation activities (such as immunoassay or PCR).
• Hands-on experience with laboratory and manufacturing equipment (e.g., pipettes, scales, peristaltic pumps, incubators).
• Familiarity with analytical procedures including qPCR, ELISA, absorbance-based spectroscopy; NGS experience preferred.
• Understanding of and experience with regulatory standards such as ISO 13485, CLIA, cGMP, and 21 CFR part 820.
• Ability to work in a BSL-2 laboratory environment, following safety protocols and using PPE consistently.
• Strong analytical thinking, organizational, multitasking, and time management skills with attention to detail.
• Comfortable adapting to shifting priorities in a dynamic work environment.
• Proficiency in Microsoft Office applications.

Published Category: Quality & Validation