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Posted Apr 27Senior Quality Control Analyst & Investigator
Hybrid
Responsibilities
- 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.
- Facilitate implementation and effectiveness checks of CAPAs across QC operations.
- Ensure CAPA actions are scientifically justified, feasible, sustainable, and compliant with regulatory expectations.
- 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.
Requirements
- CAPA Management Develop effective, preventive, and verifiable CAPAs that address identified root causes and prevent recurrence in the QC laboratory.
- Compliance & Regulatory Alignment Maintain strong working knowledge of FDA Guidance for Industry related to Out-of-Specification (OOS) results, investigations, and sterile manufacturing environments.
- Cross-Functional Collaboration Work closely with QC Chemists, Supervisors, QA, Operations, and other teams to ensure timely completion of investigations.
- 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.
Benefits
- Your Future: 401k Matching Program, 401k Plus Program, Discounted Stock Options, Tuition Reimbursement Work/Life Balance: Flexible Personal/Vacation Time Off, Paid Holidays, Flex Holidays, Paid Community Service Day Your Wellbeing: Medical, Dental, Vision, Health Savings Account (Employer Contribution of $500+ annually), Employee Assistance Program, Parental Leave, Fertility and Adoption Assistance Program Flexibility: Hybrid Work Model (For most professional roles) Training: Hands-On, Team-Customized,
Contact
- Inclusion and Belonging - Committed to Welcoming, Celebrating and Thriving on Inclusion and Belonging, Learn more about Employee Inclusion Groups on our website (https://www.smith-nephew.com/).
Additional details
- At Smith+Nephew we design and manufacture technology that takes the limits off living.
- 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.
- This individual will also ensure investigation integrity by preventing “testing into compliance” and by developing sound, scientifically justified retest strategies when appropriate.
- 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.
- Partner with chemists and laboratory teams to gather data, evaluate analytical methods, and review sample preparation and execution details.
- 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.
- Provide coaching and guidance to QC analysts on investigative expectations and best practices.