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QC Microbiology Associate II

Thermo Fisher Scientific’s Viral Vector Services (VVS) is a rapidly growing, multifaceted 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 department and help lead our organization into the future.

Location: Plainville, MA

Shift: Wednesday - Saturday (4 x 10 Hour Shifts)

The QC Microbiology Associate II will be an integral member of the group ensuring operational readiness of the lab followed by performing Microbial testing to support GMP production. The key focuses will be to assist in the timely completion of in-process and release testing of clinical and commercial grade biopharmaceuticals, qualification/validation of analytical methods for support of viral vector cGMP compliant manufacturing and the transfer and validation of methods from clients. The incumbent will act as an analyst in the lab by assisting in routine testing, equipment setup, documentation, analytical method transfer / qualification, training, and keeping up cGMP compliance practice to support group needs.

What you will do...

• Perform routine environmental monitoring and critical utility testing
• Contribute to writing of SOPs if needed.
• Maintain the necessary compliance status required by company and facility standards.
• Conduct routine microbiology assays including bioburden, endotoxin testing, growth promotion, plate enumeration, and microbial identification.
• Perform all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, and Safety guidelines.
• Take part in process improvement initiatives & having a voice within the department.
• Recognize and report out-of-specification or unexpected results.
• Assist in preparing regulatory documents and other communications with outside agencies, clients, and/or colleagues from other corporate sites.
• Perform daily lab cleaning, preventative maintenance of equipment, ordering of supplies, and autoclaving of equipment.
• Record and report results of analysis in accordance with prescribed lab procedures and systems.
• Clearly and accurately communicate the results of work by capturing of the testing/analysis and obtained results.

How will you get here?

• Bachelor’s degree in science; preferably Microbiology or Biology

• 1+ years of relevant experience within a laboratory setting.
• Equivalent experience working in a cGMP environment preferred

• Ability to function in a constantly evolving environment.
• Knowledge of GMP regulations in cGMP manufacturing environment preferred.
• Excellent problem solving and critical thinking skills
• Must be fluent in English
• Excellent organization and planning skills.
• Strong attention to detail and ability to adhere to standard procedures.

What we offer…

• Company Paid Parental Leave
• Tuition Reimbursement – eligible after 90 days
• Employee Referral Bonus
• Charitable Gift Matching
• Employee Discount Program
• Paid Time Off & Holidays
• Medical, Dental, & Vision benefits-effective Day 1
• Recognition Program
• 401K Company Match up to 6%*
• Review our company’s Total Rewards
• Career Advancement Opportunities

• Eligibility timeline may vary

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. A one 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.

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.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.

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