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Thermo Fisher Scientific QC Associate II, Raw Materials in Plainville, Massachusetts

Job Title: QC Raw Material Associate II

Requisition ID:

Location: PLA

Who are we?

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.

How will you make an impact?

The QC Raw Material Associate II provides critical sampling activities of the raw materials that will be used to manufacture innovative viral vector therapies to our clients. The Plainville, Massachusetts site is a brand-new site currently in construction. This new team will be essential to the start up of the facility and the timely delivery of these critical therapies.

What will you do?

  • Raw Materials Inspection: to include but not limited to; Review of received goods, documenting appropriate particulars (e.g. lot numbers, expiry dates, etc), cross referring information against documentation, rejecting incorrect goods and notifying appropriate personnel

  • Raw Material Sampling: Arrange and collection, labelling and storage of samples where required.

  • Ship raw materials for testing to external/internal laboratories

  • Reconcile test results for release of GMP materials

  • Identify, communicate, and support investigations for any identified internal and/or external non-conformances, identified during QC checks, or notified to QC by another function.

  • Performing documentation review of general processing documents such as, but not limited to; Receipt Records and Laboratory Processing Records

  • Performing additional QC check duties as identified by the QC Team Manager

  • To ensure during review documentation is correct, GMP compliant, error-free, and entered operating systems appropriately.

  • Perform ad hoc duties, as requested by the QC Team Manager or Senior Manager, Quality, to support activities of the Quality department.

How will you get here?

  • High School Diploma/GED

  • Experience working in a GMP (GxP) environment (desirable)

  • Knowledge in the use of Pharmacopeia such as USP, EP and JP preferred

  • Strong problem solving and decision-making skills

  • Requires good written, verbal, and interpersonal communication skills and the ability to effectively interact with all levels.

Knowledge, Skills, Abilities

  • Ability to handle multiple assignments and changing priorities.

  • Positive, proactive approach to drive assignments/tasks to completion.

  • Ability or capable of lifting twenty (20) lbs, with or without accommodation

  • A high degree of accuracy and attention to detail

  • Ability to read and interpret general procedures

  • Ability to calculate figures and amounts such as percentages

  • Proficient in personal computer skills; specifically, Microsoft Office, Outlook and database management

  • Ability to demonstrate experience of working without direct supervision/under own initiative within the remit of the role

Although not essential, the following skills and experience would be preferred:

  • 1-3 years’ experience in the pharmaceutical industry or related GMP environment.

  • Associates Degree with 3-5 years’ experience in lab operations (Pharmaceutical environment preferred) and a working knowledge of SAP software application systems (Pharmaceutical preferred).

Additional Information:

  • May include working with dry ice, liquid nitrogen cryogenics, hazardous and infectious agents, as well as marked changes in temperature

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.