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Thermo Fisher Scientific Quality Control Lead Investigator in Bedford, Massachusetts

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.

The BioProduction Division is one of the fastest growing businesses in the company, supporting developers and manufacturers of biological-based therapeutics and vaccines. ​With our portfolio of best-in-class products that span the bioprocessing workflow from discovery through large-scale commercial production, our business is driving performance in bioprocessing through collaboration with our customers .

How will you make an impact?

Within the Quality organization of the Bedford, MA facility, we are seeking a skilled Quality Control Lead Investigator who will be motivated by this exciting opportunity for a technically minded Laboratory Professional looking to develop as an independent contributor.

You'll be a capable Investigator with experience in working with a cross functional team to drive to true root cause and implementing effective corrective action plans

What will you do?

Supporting the Quality Organization, the QC Lead Investigator will:

  • Lead investigator for the quality control group owning OOS and deviation records

  • Using data and root cause analysis tools to find true root cause for problem records

  • Implement and drive effective corrective action plans.

  • Work on quality control change requests including revisions to SOPs.

  • Act as an approver for cross functional change request, OOS, and deviation records

  • Review in-process and final batch testing data to release to our customers.

  • Work independently and as part of a team.

How will you get here?

Education and Experience

  • Bachelors in relevant scientific discipline with 3+years of relevant experience, an associates degree in relevant scientific discipline with 5+ years of relevant experience, or a high school degree with 7+ years of relevant experience.

  • Experience working on OOS/deviation investigations in a cGMP or cGMP like environment

Knowledge, Skills, Abilities

  • Knowledge of Quality standard (e.g., ISO 13485, FDA, ICH) guidelines

  • Familiar with SAP, Agile, E1, LIMS or other electronic data/document management systems.

  • Proven ability to execute project tasks with minimal supervision.

  • Flexibility to adapt to a dynamic environment and manage activities to meet the needs of the business while maintaining a focus on quality.

  • Familiar with continual process improvement practices such as Kaizen, Gemba, 3P, 5S, Standard Work and others.

  • Excellent inter-personal, communication and organizational skills with good attention to detail.

At Thermo Fisher Scientific, each one of our 75,000 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.

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