Quality Control Specialist, Analytical

The QC Specialist, Analytical supports the quality and compliance of cell therapy programs through a focus on data review, investigations, and quality systems. This role plays a key part in ensuring that QC methods, analytical data, and documentation meet cGMP requirements and regulatory expectations for clinical and commercial manufacturing. Working cross‑functionally with Quality Assurance, Analytical Development, and Manufacturing, this position emphasizes technical writing, data analysis, and product quality oversight.

While maintaining a strong understanding of laboratory operations, the role is not primarily focused on routine bench work.

• Lead and support investigations related to deviations, OOS/OOT/invalid results, and CAPAs, ensuring thorough root cause analysis and clear documentation.
• Review QC data, laboratory records, and analytical results to assess product impact and ensure compliance with cGMP standards.
• Author and review SOPs, test methods, validation protocols/reports, and investigation summaries.
• Perform data trending and analysis to identify variability, shifts, or emerging risks in QC and product quality data.
• Support method lifecycle activities including qualification, validation, transfer, and periodic review in collaboration with Analytical Development.
• Provide technical oversight of QC methods to ensure they remain scientifically sound and fit for purpose.
• Contribute to change control activities and assess potential impact to product quality and method performance.
• Support maintenance of product specifications, including acceptance criteria and scientific justification.
• Participate in stability program activities, including data review and trending to support shelf‑life determinations.
• Ensure accurate, complete, and compliant GMP documentation in alignment with data integrity (ALCOA+) principles.
• Support audits and regulatory inspections by preparing and reviewing technical documentation.
• Collaborate cross‑functionally with QA, Manufacturing, and external partners to support product quality objectives.
• Contribute to quality risk assessments (ICH Q9), continuous improvement initiatives, and quality system enhancements.

• Bachelor’s degree in Life Sciences, Biotechnology, or related field (advanced degree preferred).
• 5–8+ years of experience in GMP Quality Control, Quality Assurance, or related function within biotech or pharmaceutical industry.
• Strong knowledge of cGMP, FDA/EMA regulations, and ICH guidelines.
• Experience with deviation investigations, OOS/OOT, CAPAs, and change control processes.
• Strong technical writing, data analysis, and problem‑solving skills.
• Working knowledge of analytical methods such as flow cytometry, PCR, ELISA, and bioassays.
• Excellent communication skills and ability to collaborate in a cross‑functional environment.
• High attention to detail and commitment to quality and compliance.
• Primarily office‑based with occasional presence in laboratory or manufacturing areas as needed.
• Ability to sit or stand for extended periods and move throughout the facility.
• Ability to gown and enter classified areas when required.
• Ability to lift and carry up to 40 lbs as needed.