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Work Schedule

Second Shift (Afternoons)

Environmental Conditions

Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cold Room/Freezers -22degreesF/-6degrees C, Laboratory Setting, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Strong Odors (chemical, lubricants, biological products etc.)

Job Description

Location/Division Specific Information

**Location:** Plainville, MA

Schedule/Hours:** M-F 8-4:430 *** Shift will transition to Sun-W 2nd Shift (1:00PM-11:30PM)

Thermo Fisher Scientific’s Viral Vector Services (VVS) is a rapidly growing, 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.

How will you make an impact?

The Sr QC Technician is an integral member of the QC Team ensuring the appropriate samples are submitted and received into the QC for testing from the Manufacturing floor, as well as from clients, to support GMP production. The key focuses will be to assist in the timely receipt of in-process and release samples of clinical and commercial samples, the receipt of in-house raw materials requiring testing, preparation of paperwork and coordination of shipments of samples to off-site and the generation of Certificate of Analysis from the completed testing.

What you will do?

+ Receive, log in and store all samples submitted

+ Prepare submission paperwork for contract testing laboratories and ship samples in coordination with Logistics department.

+ Coordinate quote generation with contract test labs and generate PO requests

+ Lead sample disposal in LIMS

+ Generation of COT/COAs in LIMS and document management system

+ Maintain the laboratory inventory and supply stocking system with input from area owners

+ Perform routine laboratory cleaning

+ Review electronic logbooks for accuracy

+ Perform lab walk through inspections

+ Enter repair requests in work order system

+ Follow written standard operating procedures

+ Maintain and ensure safe laboratory environment and work practices

+ Update and approve SOPs within the documentation system

How you will get here?

Education

+ Bachelor’s degree in sciences or related field. Biological sciences is preferred.

Experience

+ 0 + years of GMP experience required.

Knowledge, Skills, Abilities

+ Ability to gown and gain access to cleanroom areas

+ Position requires frequent standing, bending, stopping, and the ability to lift 40 lbs.

+ Ability to work with strong chemical odors such as Spor-Klenz and bleach.

+ 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 10 hour shift which includes one weekend day.

+ Occasional off shift or weekend hours may be required to meet business needs.

+ Strong communication skills (verbal and written).

+ Good autonomous problem-solving skills.

+ Strong attention to detail.

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.