Senior Quality Control Analyst & Investigator

What will you be doing?

Laboratory Investigations
Lead and conduct comprehensive QC laboratory investigations for OOS, OOT, deviations, atypical results, and invalidations.
Apply deep investigative rigor to determine true root cause, using data-driven, scientifically sound methodologies.
Ensure all investigations comply with FDA guidance, cGMPs, and expectations for sterile drug-product manufacturing environments.
Develop and document robust investigation reports that are accurate, concise, and fully defensible during internal or regulatory audits.
Partner with chemists and laboratory teams to gather data, evaluate analytical methods, and review sample preparation and execution details.
CAPA Management
Develop effective, preventive, and verifiable CAPAs that address identified root causes and prevent recurrence in the QC laboratory.
Facilitate implementation and effectiveness checks of CAPAs across QC operations.
Ensure CAPA actions are scientifically justified, feasible, sustainable, and compliant with regulatory expectations.

What will you need to be successful?

• Required 8–10 years of extensive experience in Quality Control within the pharmaceutical or biotech industry.
• Strong experience conducting and documenting QC laboratory investigations.
• Demonstrated ability to identify true root cause using tools such as 5 Whys, Fishbone, Fault Tree Analysis, and data trending.
• Deep knowledge of FDA OOS guidance, cGMP for laboratory controls, and requirements for sterile drug product manufacturing.
• Strong technical understanding of analytical chemistry, method execution, laboratory instrumentation, and data review.
• Experience developing effective CAPAs and driving implementation.
• Strong communication skills and the ability to work collaboratively across teams.

Core Competencies

• Investigative Rigor & Scientific Judgment
• Regulatory and Compliance Excellence
• Collaboration & Teamwork
• Analytical/Technical Problem Solving
• Documentation Quality
• Decision Making with Integrity