Senior Quality Control Analyst & Investigator

Senior Quality Control (QC) Analyst & QC Investigator The Senior QC Analyst & QC Investigator is an experienced, highly skilled individual contributor responsible for leading and executing thorough, compliant laboratory investigations within the Quality Control organization. This role requires deep expertise in identifying true root causes, preventing recurrence through effective CAPA development, and ensuring that all laboratory investigations meet FDA expectations for operations within a sterile drug product manufacturing environment. 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. Compliance & Regulatory Alignment Maintain strong working knowledge of FDA Guidance for Industry related to Out-of-Specification (OOS) results, investigations, and sterile manufacturing environments. Ensure all investigative actions and documentation align with regulatory expectations and withstand regulatory scrutiny. Prevent testing into compliance by ensuring investigative integrity and scientifically justified decision‑making. Support audit readiness and provide SME support during regulatory inspections as needed. Retest and Resample Strategy Develop compliant, scientifically defensible retest, resample, or reanalysis plans when justified by the investigation. Work with analytical teams to ensure retest plans are executed properly and results are understood within proper regulatory context. Cross-Functional Collaboration Work closely with QC Chemists, Supervisors, QA, Operations, and other teams to ensure timely completion of investigations. Provide coaching and guidance to QC analysts on investigative expectations and best practices. Serve as an SME for laboratory investigation processes, root-cause analysis tools, and documentation standards. 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. Preferred Bachelor’s or advanced degree in Chemistry, Microbiology, Biochemistry, or related scientific discipline. Experience supporting regulatory inspections and acting as an SME. Experience in sterile manufacturing environments and aseptic processing quality expectations. Core Competencies Investigative Rigor & Scientific Judgment Regulatory and Compliance Excellence Collaboration & Teamwork Analytical/Technical Problem Solving Documentation Quality Decision Making with Integrity U.S. Sponsorship or H1B transfer is not available for this role. Smith+… provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability. #J-18808-Ljbffr Dormont Manufacturing Co