QC Specialist

Duration: 12-Month Contract

Schedule: 40 Hours/Week

Start Date: ASAP

Our biopharmaceutical client is seeking a QC Specialist to support a Quality Control organization responsible for analytical review activities across both commercial and clinical-stage programs. This individual will be responsible for reviewing and approving GMP analytical data, supporting batch release activities, reviewing stability and in-process testing results, managing analytical investigations, and collaborating with external testing partners.

The ideal candidate will possess a strong analytical chemistry background combined with experience reviewing GMP documentation, analytical data packages, and vendor-generated testing records. This role offers a unique opportunity to gain exposure to both clinical and commercial products while working closely with internal stakeholders and contract laboratories.

Due to a significant increase in analytical review workload, the team is seeking an experienced QC professional who can quickly contribute in a fast-paced, highly collaborative environment.

• Review and approve GMP analytical data supporting drug product release, stability studies, raw materials, and in-process testing activities.
• Perform analytical review of Certificates of Analysis (CoAs), batch release documentation, and supporting analytical records.
• Review vendor-generated analytical data packages and verify accuracy, completeness, compliance, and alignment with approved analytical methods.
• Evaluate analytical results, calculations, chromatograms, trends, and supporting raw data to ensure data integrity and GMP compliance.
• Create and utilize calculation spreadsheets to independently verify analytical results and support analytical data review.
• Support analytical review activities associated with clinical and commercial manufacturing programs.
• Perform CoA review and support product disposition and batch release activities.
• Support investigations associated with analytical quality events, including OOS (Out-of-Specification), OOT (Out-of-Trend), atypical results, deviations, and CoA-related discrepancies.
• Collaborate with external testing laboratories, CMOs, and contract testing partners to review analytical findings, resolve data questions, and support investigation activities.
• Participate in technical discussions with vendors regarding analytical methods, test results, quality events, and data interpretation to ensure scientifically sound and compliant outcomes.
• Challenge and elevate analytical conclusions, data inconsistencies, or documentation deficiencies when additional clarification, justification, or investigation is required.
• Assist with in-process testing review and stability program support activities.
• Collaborate across Quality, Analytical Development, Manufacturing, Regulatory, and external partner organizations to drive timely resolution of analytical and compliance-related issues.
• Maintain accurate documentation and ensure compliance with applicable GMP regulations and internal quality systems.
• Demonstrate a strong GMP mindset and ability to identify potential compliance risks before they impact product quality or release timelines.

• Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related scientific discipline.
• 4-8 years of pharmaceutical or biotechnology industry experience in Quality Control, Analytical Chemistry, or a related GMP environment.
• Demonstrated experience reviewing and approving GMP analytical data and supporting documentation.
• Strong understanding of analytical chemistry principles, chromatographic data analysis, and pharmaceutical analytical testing.
• Experience supporting:
• Batch release activities
• Stability programs
• In-process testing
• Certificate of Analysis (CoA) review
• Analytical investigations
• Experience reviewing analytical data packages generated by external laboratories, CMOs, CROs, or contract testing organizations.
• Ability to effectively communicate with external testing partners to resolve analytical questions, investigations, and documentation issues.
• Hands-on experience with Waters Empower and/or Agilent Open Lab
• Strong understanding of GMP regulations, laboratory documentation practices, and data integrity principles.
• Ability to independently identify analytical discrepancies, investigate issues, and communicate findings effectively.
• Strong organizational skills with the ability to manage multiple priorities in a high-volume environment.
• Excellent…