**Work Schedule** First Shift (Days) **Environmental Conditions** Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Laboratory Setting, No contact lens allowed; prescriptive glasses will be provided, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Standing for full shift, Various outside weather conditions **Job Description** At Thermo Fisher Scientific team, you’ll discover impactful work, innovative thinking and a culture dedicated to working the right way, for the right reasons - with the customer always top of mind. The work we do matters, like helping customers find cures for cancer, protecting the environment, and making sure our food is safe. As the world leader in serving science, with the largest investment in R&D in the industry, our colleagues are empowered to realize their full potential as part of a fast-growing, global organization that values passion and unique contributions. Our commitment to our colleagues across the globe is to provide the resources and opportunities they need to make a difference in our world while building a fulfilling career with us. **Location/Division Information** Clinical Diagnostics Division in Middletown, VA. This position is for the 1st shift, which typically starts between 6:00 AM and 8:00 AM. **Major Responsibilities:** + Lead Out-of-Specification (OOS) investigations from initiation through final report completion, including cross-functional collaboration and root cause analysis. + Perform NCR/CAPA root cause investigations with detailed analysis and documentation. + Complete MOC/CO (Management of Change/Change Orders) processes. + Serve as subject matter expert on specific areas and/or instruments, providing technical mentorship to cross-functional teams. + Prioritize and manage daily/weekly QC laboratory testing schedules for assigned area(s) with strategic operational oversight. + Coordinate daily scheduling activities when Team Lead position is not present in assigned area. + Supervise and uphold re-examination/reassessment procedures for raw materials to guarantee regulatory adherence and operational effectiveness. + Implement detailed departmental data review for raw materials, in-process samples, release-to-fill samples, component samples, final kit samples, stability samples, and IAR samples. + Run tier boards and facilitate technical discussions with cross-functional teams and management. + Preserve instruments/equipment following manufacturers' instructions and internal audit and calibration protocols. + Ensure all laboratory activities align with cGMP, GLP, and ISO requirements. + Keep accurate records/logs as per established procedures and regulatory requirements. + Support business continuity through cross-training and coverage of critical laboratory functions. **Minimum Requirements/Qualifications:** + Bachelor's degree in Chemistry, Biology, or related scientific field preferred, or equivalent experience. + 3+ years of laboratory experience. **Benefits** We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation! Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.