Quality Control Specialist

Role: QC Specialist supporting External Testing in biopharma, primarily focused on analytical data review for Advanced Therapies. Responsibilities include verifying test results for Release, In-Process, and Stability testing, ensuring compliance with cGMP, FDA, EMA, ICH, and data integrity principles (ALCOA+). The role also involves evaluating validation documentation, monitoring testing procedures, collaborating with laboratory staff for quality improvements, and supporting deviation investigations. Qualifications: BS/BA in a scientific field with at least 2 years of GMP-related experience; technical expertise in analytical methods such as LC, pH, iCIEF, ELISA, SEC, and CE-SDS. Preferred: experience in biologics, cell/gene therapy, or advanced therapies; familiarity with regulatory guidelines and data integrity standards. High-Value: supporting quality assurance in advanced therapies (biologics/cell/gene), cGMP environment, analytical testing, data review, and documentation practices. Work Setup: Monday-Friday, 8:00 am–4:30 pm, on-site; no explicit travel requirements.