Analyst III QC Microbiology - Wed - Sat

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.
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 Analyst III 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 Wednesday-Saturday 1:00pm-11:30pm.
Training will occur on first shift before analyst is transferred to second shift.
- Performs routine environmental monitoring and critical utility sampling
- Performs routine microbiology assays and method suitability testing
- Authors final reports for assay qualifications
- Interacts with clients for assay qualification activities
- Authors and execute alert/action investigations, deviations, and change controls
- Authors technical documents (SOPs, Work Instructions)
- Provides training to junior level employees
- Leads morning huddles and afternoon MDI meetings when management is not available
- Troubleshoot assay and equipment failures with analysts
- Acts as a QC Micro SME for investigations, risk assessments, and CAPAs
- Provides aseptic training to cleanroom personnel
- Coordinates QC Action Notice Release 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
- BS - in biological sciences or related field and 3 years experience - required. Master's degree and minimum of 2 years of industry experience, preferred.
Experience
- 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
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. 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. For more information, please visit www.thermofisher.com.
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.