QC Scientist I

Job Description

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 our team and help lead our organization into the future.

Location

Cambridge, MA

How will you make an impact?

The QC Scientist I 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 a SME during internal and external audits.

What will you do?

Position is Sunday-Wednesday 9:30 PM-8:00 AM.

• Performs routine environmental monitoring and critical utility sampling
• Performs routine microbiology assays and method suitability testing
• Performs sample receipt and aseptic sample aliquoting
• Performs routine environmental monitoring and critical utility sampling
• Performs routine microbiology assays
• Performs inventory and stocking of QC lab
• Reviews data and enter results into LIMS system
• Coordinates sample shipment to external labs
• Opens alert and action level quality records
• Performs routine laboratory preventative maintenance and cleaning
• Revises technical documents (SOPs, Work Instructions)
• Authors final reports for assay qualifications
• Interacts with clients for assay qualification activities

Special Requirements

• Ability to gown and gain access to cleanroom and utility areas
• Ability to work with Spor-Klenz
• Position is considered essential personnel and may be required to staff the lab during inclement weather or other internal/external emergency situations
• Rotating holiday coverage
• Occasional off shift hours may be required to meet business needs

How will you get here?

Education

• Bachelors degree B.S. in Chem Eng, Biochemistry, Biology or related field

Experience

• 1-2 years experience in science or science related fi
• Experience performing environmental monitoring, critical utility sampling, and assays
• Strong interpersonal and communications skills; written and oral
• Ability to manage timelines and meet internal/external deadlines

Weekly Covid testing will be mandatory for all employees

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