Senior Quality Control Analyst & Investigator

Smith+Nephew•Fort Worth, TX

1d•Hybrid

About The Position

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. The Senior QC Analyst will collaborate closely with chemists, laboratory staff, and cross functional partners to ensure that investigations are completed accurately, efficiently, and on time. This individual will also ensure investigation integrity by preventing “testing into compliance” and by developing sound, scientifically justified retest strategies when appropriate.

Requirements

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.

Nice To Haves

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.

Responsibilities

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.
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.
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.
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.
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.