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Qc Microbiology Team Lead

Company

Thermo Fisher Scientific

Address , Cambridge, 02139, Ma
Employment type
Salary
Expires 2023-06-09
Posted at 1 year ago
Job Description
The Quality Difference at Thermo Fisher Scientific: What makes our quality teams unique is a shared passion for getting it done right the first time and working for the right reasons with our customers always in mind. Our team of Quality professionals understand our customers rely on the accuracy, safety, and effectiveness of our products and services that are improving lives around the world. When you join our team of quality professionals, you’ll collaborate on projects on a global scale while being encouraged to grow your skills and discover new career paths with us.

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Location/Division Specific Information

Thermo Fisher Scientific's Viral Vector Services (VVS) is a rapidly growing, dynamic gene therapy, contract development and manufacturing organization (CDMO) that is seeking sharp individuals to bring the highest quality processes, products and testing to our clients. Our employees are committed to making a difference in our organization, for our client partners and the patients we serve. We are looking for top talent with proven competencies and strong character to join TFS VVS and help lead our organization into the future.

How will you make an impact?

The Team Lead will perform routine environmental monitoring, critical utility testing, and microbiological assays. Completes method suitability testing and writes final reports. The incumbent will act as a leader in the lab helping management to interview and train junior employees, schedule testing, troubleshoot assays and equipment and act as an SME during internal and external audits.

What will you do?

Position is Sunday-Wednesday 1:00pm to 11:30pm

  • Authors Technical documents (SOPs, Work Instructions, Gap Analyses)
  • Interacts with Clients for assay qualifications and onboarding activities
  • Coordinates QC return to service activities for action notices or shutdowns
  • Authors final reports for assay qualifications
  • Act as a QC Micro SME during internal/external audits, risk assessments, and investigations
  • Leads Afternoon MDI and huddle meetings
  • Provides training to junior level employees
  • Onboard new equipment with a cross functional team (Procurement, Validation)
  • Performs routine microbiology assays and method suitability testing
  • Works closely with QC Management to develop analyst training plan
  • Troubleshoots assay and equipment failures with analysts
  • Coordinates analyst/assay scheduling
  • Authors and partakes in investigations and change controls
  • Participates in recruiting and onboarding of new analysts

How will you get here?

Required Skills

  • Ability to manage timelines and meet internal/external timelines
  • Strong interpersonal skills and ability to work cross functionally with a diverse group of individuals
  • Bachelor's Degree in biological sciences and minimum of three (3) years of industry experience

Preferred Skills

  • Master's Degree and minimum of two (2) years of industry experience

Special Requirements

  • Occasional off shift or weekend hours may be required to meet business needs
  • Ability to gown and gain access to cleanroom areas
  • Position requires frequent standing, bending, stopping, and the ability to lift 40lbs.
  • Position is considered essential personnel and may be required to staff the lab during inclement weather or other internal/external emergency situations
  • Ability to work with strong chemical odors such as Spor-Klenz and bleach

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one global team of 100,000 colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today!

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.