Quality Control Specialist, Analytical
About The Position
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.
Requirements
- Bachelorâs degree in Life Sciences, Biotechnology, or related field (advanced degree preferred).
- ~5â8+ 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.
Responsibilities
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
11-50 employees
