Quality Control Specialist

About the role

Performs data review of analytical test results to support QC External Testing operations.

Responsibilities

• Conduct comprehensive data review for Release, In‑Process, and Stability testing in Advanced Therapies, ensuring adherence to quality standards.
• Perform thorough evaluation of analytical test method Qualification, Verification, Transfer, and Validation documentation.
• Ensure all data complies with cGMP, GDP, FDA, EMA, and ICH Guidelines through meticulous review processes.
• Verify analytical data meets ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, and Available).
• Monitor testing compliance with established laboratory procedures, test methods, and approved protocols.
• Collaborate with laboratory personnel to address documentation errors and omissions while fostering a cGMP‑oriented culture.
• Demonstrate exceptional attention to detail, focus, and multitasking capabilities when reviewing complex analytical laboratory data.
• Apply strong technical expertise in various analytical methodologies including liquid chromatography, pH measurement, iCIEF, ELISA, SEC, and CE‑SDS.
• Engage with team members to implement continuous improvements to data review processes and methodologies.
• Provide strategic guidance to QC analysts for enhancing Good Documentation Practices within cGMP frameworks and applicable SOPs.
• Complete assigned tasks within established timeframes while managing organizational responsibilities including tracking open tasks and timelines.
• Support the development and review of QA events, deviations, and investigations as required.
• Maintain effective communication with QC Analysts, Group Leaders, and departmental managers to ensure seamless operations and quality compliance.

Qualifications

• BS/BA in a scientific field (or equivalent combination of education and experience).
• Minimum 2 years of related experience in a GMP setting.
• Strong ability to achieve thoroughness and accuracy when performing tasks.
• Excellent prioritization, organizational, and detail‑oriented skills.
• Ability to adjust to shifting priorities, manage multiple tasks and meet deadlines.
• Excellent written and oral communication skills.
• Effective communication of issues and ideas with direct reports, peers, and management.

Schedule

1st shift, Monday‑Friday, 8:00 am – 4:30 pm.

Pay

Salary range (annually): $67,400 – $110,000.

Benefits

• Health and wellness programs
• Fitness centers
• Equity awards/stock options
• Annual bonuses or other incentive plans
• Pension or retirement benefits, including 401(k) company match
• Insurance benefits (medical, dental, vision, life, disability)
• Paid time off
• Family support benefits