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Supervisor, QC (ELISA and Bioassay)

Company: Thermo Fisher Scientific
Location: Saint Louis
Posted on: November 22, 2021

Job Description:

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 InformationThis position supports the QC Analytical team for our Biologics Division in St. Louis, MO.How will you make an impact?The QC Analytical supervisor's primary responsibility is to supervise and develop the staff to perform routine activities in accordance with cGMP regulations and ThermFisher standards to meet departmental and organizational goals. This position entails managing employees to support qualification assays, to perform transfer and validation assays, batch release, process and facility support testing to meet customer needs. The supervisor is also expected to represent the department in regulatory agency, internal and partner audits. The individual will also provide technical expertise to resolve routine to complex QC issues pertaining to ELISA and cell-based bioassays, provide assay execution support, and conduct training for QC analytical personnel. Additional responsibilities include supporting the department to establish robust work processes and assess for continuous improvement opportunities.The QC Analytical Supervisor will report directly to the QC Analytical Manager, and will manage the activities of 5-10 members of ELISA and Cell-based bioassay team.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.
  • Overall creation and coordination of work schedules for team.
  • Provide technical and compliance guidance on Test Methods, qualification, validation and transfer protocols and reports. Revise/review specifications, SOPs, and other documents regarding QC-Analytical testing and assay execution.
  • Train new hires on department processes, procedures and tools.
  • Interact with auditors/clients during visits and tours.
  • Oversee daily activity for the group to ensure appropriate quality and volumetric output and maintenance of schedules.
  • Perform in-lab assay execution support for validation, qualification studies or routine testing, when needed
  • Set objectives and tasks for staff and regularly review staff progress in meeting objectives
  • Review and approval of documentation generated by the group.
  • Lead investigations in the case of deviations, and assists in the resolution of Out of Specification (OOS), complaints, discrepancies and CAPA (corrective actions preventive actions)
  • Establish work plan and staffing for each phase of project, and arrange for assignment of project personnel
  • Notify Senior Management of potential quality or regulatory issues that may impact product quality or regulatory compliance
  • Effectively communicate with peers, manufacturing, AD and QC staff, to resolve technical issues and direct activities.
  • Provide support to site Safety initiatives.
  • Review FTE assessments to determine time frame, limitations, procedures for accomplishing project, staffing requirements, and allotment of available resources to various phases of project.
  • Perform any other tasks as requested by Senior Management to support Quality oversight activitiesHow will you get here?Education
    • Bachelor's Degree in a Biological Science related fieldExperience
      • 3+ years of related experience in the biopharmaceutical or pharmaceutical industry.
      • 2+ years of supervisory/team lead experience within the pharmaceutical industry, preferably in ELISA or cell-based bioassay field.
      • Extensive knowledge of GMP regulations in a cGMP manufacturing environment.
      • Working Knowledge of scientific principles for wide range of analytical techniques strongly preferred. ELISA and cell-based assay experience with large molecules is strongly recommended.
      • Routine use of MS Excel, MS PowerPoint, and MS Word is essentialKnowledge, Skills, Abilities
        • Ability to understand customer requirements related to Quality control, including processes and equipment.
        • Outstanding technical writing skills.
        • Strong interpersonal skills including actively listening, conflict resolution and the ability to effectively influence diverse stakeholders for positive outcome.
        • Ability to build strong relationships with client while instilling trust and confidence
        • Highly organized with attention to detail
        • Familiar with standard project management concepts, tools and responsibilities (objectives, scope, deliverables)
        • Knowledge of Qualification and Validation requirements for analytical methods
        • Ability to interpret and relate Quality Standards for implementation and review
        • Ability to make sound decisions about scheduling, allocation of resources, and managing priorities
        • Ability to communicate clearly and professionally in writing and verbally
        • Flexibility in problem solving, providing direction and work hours to meet business objectives
        • Working knowledge in 5S, SAP, Nextdocs and Trackwise preferred
        • Ability to drive functional, technical and operational excellence.
        • Ability to inspire and foster innovation, collaboration, transparency and team effectiveness.At Thermo Fisher Scientific, each one of our 70,000 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.comThermo 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.

Keywords: Thermo Fisher Scientific, St. Louis , Supervisor, QC (ELISA and Bioassay), Other , Saint Louis, Missouri

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