Manager, Upstream Investigations
Company: Thermo Fisher Scientific
Location: Saint Louis
Posted on: November 22, 2021
Manager, Upstream Investigations
When you're part of the team at Thermo Fisher Scientific, you'll do
important work, like helping customers in finding cures for cancer,
protecting the environment or making sure our food is safe. Your
work will have real-world impact, and you'll be supported in
achieving your career goals.
Location/Division Specific Information
St. Louis, MO
How will you make an impact?
This position works at the site level and is responsible for
managing a team of deviation investigators. Operate cross
functionally and collaborate with peers both inside and outside of
the Upstream Functional Areas (Engineering, Operations, and QA) to
deliver on compliance commitments and expectations.
What will you do?
* Responsible for the review and approval of major and minor
deviation investigations as a representative of the Operations
team, with an Upstream focus. Provide feedback on the technical
aspects of the investigation, the quality of the writing, and the
thoroughness of the root cause analysis. Ensure CAPA's address the
root cause and are effective.
* Coach team members on technical writing and root cause
* Track metrics on deviation rates, closure rates, root cause
* Work cross-functionally to implement process improvements to
improve KPI performance.
* Perform investigations on major/critical cross-functional
deviations, as required.
* Provide direction and balanced performance feedback, coach,
develop, and challenge direct reports, enforce company policies,
and deal with personnel issues promptly. Maintain open
communication via one-on-one and team meetings, and assure
supervisory files are kept up to date.
* Support the maturing of area systems on an annual basis
* Partner with other areas to ensure good quality and cGMP
practices with process changes
* Live the Thermo Fisher Scientific 4Is values every day. Be
How will you get here?
* Bachelor's degree required, preferably in a STEM field.
* 6+ years of industry experience, preferably in a cGMP environment
* 4+ years of experience with biologic manufacturing, upstream
* 2+ years in a people leader role
Knowledge, Skills, Abilities
* Understanding technical requirements associated with Upstream
processes and the biopharma production environment
* Experience in direct utilization of problem solving tools (RCA
tools including 5-Whys, TapRooT, Fishbone/6M, Kepnor-Tregoe,
Comparative Analysis, etc.) with demonstrated success.
* Excellent understanding of cGMP and other regulatory requirements
in the operation of cleanrooms
* Understanding of cGMP quality systems (e.g. change control,
deviations, investigations, risk assessments, driving GDP within
all documentation and records).
* Ability to work both independently and in a team environment.
* Ability to self-motivate, prioritize work and time.
* Organized, efficient, and results oriented
* Ability to follow-up on commitments and detail oriented.
* Expert in oral and written communication (verbal and written in
English), as well as social skills.
* Computer literate with Microsoft Office tools, including report
writing and graphing.
* Quality and/or Financial software (TrackWise, Documentum,
SuccessFactors, etc) skills a plus.
Keywords: Thermo Fisher Scientific, St. Louis , Manager, Upstream Investigations, Executive , Saint Louis, Missouri
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