Thermo Fisher Scientific Supervisor, QC Data Review in Saint Louis, Missouri
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
Biologics Division in St. Louis, MO.
How will you make an impact?
The QC Data Review Supervisor will ensure quality review of all raw data generated in QC testing laboratories.
What will you do?
Provide leadership to assigned staff by performing the following: leading organizational change; developing and empowering staff; cultivating relationships; putting staff in a position to succeed, meeting their personal career goals while also achieving organizational goals; building effective teams that apply their diverse skills and perspectives to achieve common goals; driving engagement and creating a climate where staff are motivated to do their best.
Review FTE assessments to determine time frame, limitations, procedures for accomplishing task, staffing requirements, and allotment of available resources to various tasks.
Responsible for supervision of all QC Data Reviewers and ensures tasks are on schedule.
Coordinate review activities with different teams (eg. QC testing groups, QC Leads, QC Stability, AFS, etc)
Responsible for overall quality of review in the QC department, with high emphasis on data integrity
Provides group metrics to capture Right First Time and On Time Delivery for review
Advocates and leads operational improvement initiatives related to overall QC data review program
Performs raw material, microbiological and complex analytical data review, including Certificate of Testing, Specification, and electronic data system (eg. gLIMS, PIMS)
Participation in regulatory, internal and client audits for data review questions. Performs own audit of the team data review performance.
Performance management for staff
Carries out duties in compliance with all local, state and federal regulations and guidelines including FDA, EPA, and OSHA.
Complies with all company and site policies and procedures. Reports any non-conformances. Initiates and/or leads resolution efforts and laboratory investigations.
Performs other duties as assigned
How will you get here?
- Bachelor's Degree in a Biological Science (preferably Chemistry, Biochemistry) related field required and 8+ years related experience in biopharmaceutical or pharmaceutical industry.Advanced Degree in a Biological Science (preferably Chemistry, Biochemistry) related field preferred and 4+ years related experience in biopharmaceutical or pharmaceutical industry.
At least three years supervisory/ team lead experience within the pharmaceutical industry.
Extensive knowledge of GMP regulations in cGMP manufacturing environment.
Extensive knowledge of scientific principles for wide range of analytical techniques (Chromatography, Capillary Gel Electrophoresis, DNA, Spectrophotometry, ELISA, Cell Based Assay), microbiological techniques and wet chemistry (per USP, EP, JP, etc)
Prior experience participating in analytical method development, qualification, validation and transfer as a lab scientist or client liaison, is highly recommended.
Knowledge, Skills, Abilities
Working knowledge of cGMPs and Quality Control regulatory requirements
Routine use of MS Excel, MS PowerPoint, and MS Word is essential
Comfortable with electronic systems (LIMS) and laboratory equipment (e.g. chromatography, PA800, Plate readers, etc) to be able to perform audit trail of testing records
Proven management skills, highly organized, excellent time management skills, attention to detail and have a questioning attitude
Technically competent, and thorough knowledge of scientific principles pertaining to analytical and microbiological data being reviewed
Excellent verbal and written communication skills
Strong interpersonal skills including actively listening, conflict resolution and the ability to effectively influence diverse stakeholders for positive outcome.
Ability to inspire and foster innovation, collaboration, transparency and team effectiveness.
Ability to work in a collaborative team environment
Ability to deal with multiple and changing priorities
At Thermo Fisher Scientific, each one of our 65,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission-enabling our customers to make the world healthier, cleaner and safer.
Apply today! http://jobs.thermofisher.com
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.
Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.