Staff QA Engineer

Thermo Fisher Scientific•St. Louis, MO

5d•Onsite

About The Position

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, making sure our food is safe and delivering COVID-19 solutions. 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. DESCRIPTION: The Senior Quality Engineer is a seasoned Quality Assurance professional who provides quality leadership for program commercialization, drives cross-functional quality projects and continuous improvement, and strengthens team capability through peer coaching and development. This role ensures compliant, inspection-ready execution across GMP operations from late-stage development through commercial launch, while proactively identifying and reducing quality and compliance risk. What will you do? Program commercialization & lifecycle quality leadership Serve as Quality representative/lead on cross-functional program teams to enable successful commercialization readiness (late-stage development through launch and post-launch support). Provide phase-appropriate QA oversight for technology transfer, process validation/PPQ readiness, control strategy implementation, and manufacturing scale-up activities. Partner with Product/Program Leadership to ensure quality deliverables, timelines, and risk mitigations are built into program plans (e.g., risk assessments, readiness reviews, documentation strategy). Ensure alignment to applicable regulations and guidance (e.g., FDA/EMA/ICH) and site quality standards. Quality oversight (on-the-floor and quality systems execution) Provide quality-minded problem resolution on the manufacturing and/or QC floor; identify, escalate, and drive closure of quality issues impacting safety, compliance, supply, or schedule. Review and approve GMP records including (but not limited to) batch records, SOPs/controlled documents, deviations, CAPAs, change controls, investigations, validation/transfer protocols, and other quality records. Perform routine quality walkthroughs and support a strong Quality on the Floor presence; ensure timely and effective follow-up on observations. Quality projects & continuous improvement (ownership and delivery) Lead and deliver quality and compliance projects (site and program-level), such as: deviation reduction, right-first-time improvements, audit readiness enhancements, documentation simplification, and system/process harmonization. Use risk-based thinking to prioritize work, recommend mitigation strategies, and measure effectiveness (KPIs/metrics, trending, recurring issue elimination). Drive sustainable outcomes by partnering with Manufacturing, QC, MSAT/Process Development, Engineering, Supply Chain, and other stakeholders. Peer development & informal people leadership Mentor and coach QA engineers and cross-functional peers on investigations, documentation practices, GMP decision-making, and risk-based problem solving. Support onboarding/training (curriculum completion, role-based training content, job aids) and promote consistent application of quality standards. Act as a go-to SME for assigned areas/systems and model strong quality culture behaviors (calm escalation, clear decisions, constructive challenge).

Requirements

Bachelor’s degree in biology, biochemistry, chemistry or other science related field preferred or equivalent experience in lieu of education requirements.
7+ years of experience within a GMP Environment, with strong experience in Quality Assurance/Quality Operations/Compliance
Demonstrated experience supporting tech transfer and/or commercialization readiness (late-stage development through commercial manufacturing).
Experience leading cross-functional initiatives or complex quality projects (scope, timeline, stakeholders, deliverables).
Knowledge of industry standards and cGMP regulations.
Strong working knowledge of cGMP and applicable global regulations/guidance (FDA/EMA/ICH).
Proven investigation/CAPA/change control capability with sound risk-based decision making.
Strong communication skills (written, verbal) with the ability to influence without authority and drive timely closure.
Comfortable working in controlled environments/cleanrooms and able to aseptically gown as required.
Able to perform job functions with minimal guidance and manage multiple priorities.
Proven ability to make key and timely decisions.
Proven ability to influence others and lead significant change.
Able to work collaboratively with various departments in the organization and clients to identify and implement solutions to address quality/compliance issues.
Excellent organizational skills and problem-solving abilities.
Able to aseptically gown and work in environmental clean rooms, as needed.
Able to complete job functions under minimum guidance or oversight from other Quality Engineers or manager.
Ability to work 8-hour fixed schedule onsite with possible weekend work or on call coverage.
Must be legally authorized to work in the United States now and in the future, without sponsorship.
Must be able to pass a comprehensive background check, which includes a drug screening.

Nice To Haves

Familiarity with common quality systems/tools (e.g., TrackWise, SAP, Documentum or equivalent) preferred.
Technical knowledge of biopharmaceutical manufacturing is desirable.

Responsibilities

Program commercialization & lifecycle quality leadership Serve as Quality representative/lead on cross-functional program teams to enable successful commercialization readiness (late-stage development through launch and post-launch support).
Provide phase-appropriate QA oversight for technology transfer, process validation/PPQ readiness, control strategy implementation, and manufacturing scale-up activities.
Partner with Product/Program Leadership to ensure quality deliverables, timelines, and risk mitigations are built into program plans (e.g., risk assessments, readiness reviews, documentation strategy).
Ensure alignment to applicable regulations and guidance (e.g., FDA/EMA/ICH) and site quality standards.
Provide quality-minded problem resolution on the manufacturing and/or QC floor; identify, escalate, and drive closure of quality issues impacting safety, compliance, supply, or schedule.
Review and approve GMP records including (but not limited to) batch records, SOPs/controlled documents, deviations, CAPAs, change controls, investigations, validation/transfer protocols, and other quality records.
Perform routine quality walkthroughs and support a strong Quality on the Floor presence; ensure timely and effective follow-up on observations.
Lead and deliver quality and compliance projects (site and program-level), such as: deviation reduction, right-first-time improvements, audit readiness enhancements, documentation simplification, and system/process harmonization.
Use risk-based thinking to prioritize work, recommend mitigation strategies, and measure effectiveness (KPIs/metrics, trending, recurring issue elimination).
Drive sustainable outcomes by partnering with Manufacturing, QC, MSAT/Process Development, Engineering, Supply Chain, and other stakeholders.
Mentor and coach QA engineers and cross-functional peers on investigations, documentation practices, GMP decision-making, and risk-based problem solving.
Support onboarding/training (curriculum completion, role-based training content, job aids) and promote consistent application of quality standards.
Act as a go-to SME for assigned areas/systems and model strong quality culture behaviors (calm escalation, clear decisions, constructive challenge).