Supervisor, Quality Control – Controls Value Stream

Local Jobs Thermo Fisher Scientific in QA Engineer
  • United States, Fremont, CA 94536 View on Map
  • Post Date : September 16, 2020
  • Apply Before : October 16, 2020
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Job Description

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them.
How will you make an impact?

The QC Supervisor will have direct supervision of QC Scientists / Engineers according to established policies and under management guidance. Review product batch records to disposition intermediates, and/or finished goods. Administer company policies that directly affect QC personnel. Responsibilities include interviewing, hiring and training employees; resource planning, assigning and directing work; appraising performance and disciplining employees.

What will you do?

  • Manage and coordinate the activities of the Controls QC group (MAS, Cascadion, and Proficiency product lines) and directly provide guidance to the QC Scientists / Engineers to achieve site goals, and to complete assignments and projects, as well as adhere to production schedules.
  • Conduct routine analysis of filled reagents and/or finished kits according to approved procedures.
  • Review and approve QSR documentation in order to support compliance and quality requirements.
  • Perform and support the investigations for out of specification failures, nonconformance reports, and CAPAs.
  • Provide for the continual development and training of QC Scientists / Engineers.
  • Assure compliance with QSRs and ISO regulations in the performance of department responsibilities.
  • Actively manage the continual improvement of the group to ensure full compliance of all QSRs and ISO regulations, and site initiatives.
  • Support the transfer of new products into Production.
  • Perform other responsibilities to support the needs of the department as assigned by the Sr. Manager.

How will you get here?

  • Minimum BS/BA in Chemistry, Biochemistry, or Bioscience with 5 years Quality Assurance/Quality Control experience; or 3 years and an advanced degree or equivalent work experience.
  • Direct supervisory experience preferred.
  • Strong command of Quality System Regulations and ISO.
  • Skilled at analyzing data and summarizing results, as well as generating performance metrics to drive corrective actions.
  • Strong math skills including calculation of concentrations and dilutions and a strong grasp of algebraic concepts.
  • Strong troubleshooting skills.
  • High level of reading comprehension skills.
  • Ability to follow written and verbal directions with a high level of accuracy.
  • Working knowledge of clinical analyzers is preferred.
  • Must be able to write clear, understandable documentation.
  • High level of verbal communication skills, and functional leadership skills.
  • Strong word processing and spreadsheet software skills.
  • Strong organizational skills to be able to manage multiple tasks simultaneously, and the ability to appropriately prioritize tasks.

Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon.

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