Quality Control Specialist, Analytical

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.

Required Qualifications (Must‑Haves)

• 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.

Work Environment & Physical Requirements

• 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.