Quality Assurance for Quality Control Sr. Specialist

Job Summary

Are you ready to take a leadership role in maintaining stellar quality standards at a state-of-the-art facility? We are seeking a Sr. Specialist of QA for QC to provide expert quality oversight, guidance, and critical decision-making for Quality Control (QC) equipment moves, qualifications, and decommissioning. Join a top-tier global biopharmaceutical leader and champion a culture of quality across our GxP and GMP laboratories.

location

Norwood, Massachusetts

job type

Contract

salary

$70 - 77 per hour

work hours

9 to 5

education

Bachelor's degree in Biology, Chemistry, Biochemistry, Engineering, or a related scientific field.

Responsibilities

• Review and approve critical documentation for QC laboratory equipment, including validation protocols, reports, and method SOPs.
• Act as the Quality Lead to identify, review, and approve deviations, change controls, work orders, and CAPAs related to QC instrument activities.
• Empower laboratory staff by ensuring strict adherence to Good Documentation Practices (GDP) and Data Integrity requirements.
• Perform essential reviews of QC logbooks and execute operational quality tasks precisely as defined in internal SOPs.
• Support audit and inspection readiness by ensuring all equipment records are accurately maintained and readily available.

Qualifications

• Experience: 3-8 years of experience in CQV (Commissioning, Qualification, and Validation) within a GMP regulated biotech or pharmaceutical environment.
• Strong working knowledge of FDA, EU, and ICH guidelines.
• Hands-on experience managing deviations, change controls, and risk assessments.
• Technical proficiency in digital validation software (e.g., Kneat or equivalent).

skills

• Good Manufacturing Practices (GMP)
• Quality Control (QC)
• Food and Drug Administration (FDA)
• International Council for Harmonization (ICH)

Benefits

• medical
• prescription
• dental
• vision
• AD&D
• life insurance
• short-term disability
• 401K plan