QC Specialist

Duration: 12-Month Contract Schedule: 40 Hours/Week Start Date: ASAP Position Summary 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. Key Responsibilities 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. Required Qualifications 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 OpenLab 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 communication and cross-functional collaboration skills. Preferred Qualifications Small molecule pharmaceutical experience. Experience assessing vendor investigations, deviations, OOS/OOT events, and corrective actions. Experience working directly with contract testing laboratories, CMOs, or CROs to support analytical issue resolution and product release activities. Exposure to both clinical and commercial manufacturing programs. Familiarity with vendor management and oversight of external analytical testing partners. Why This Opportunity? This role offers the opportunity to join a newly established QC organization that supports both clinical and commercial products , providing exposure to the full product lifecycle from development through commercialization. The successful candidate will gain valuable experience performing analytical quality review, supporting vendor interactions, managing analytical investigations, and contributing to critical product release activities. #J-18808-Ljbffr