Job Description

　　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.

　　At Viral Vector Services (VVS) a division of Thermo Fisher Scientific we deliver, from process development through commercial supply, we offer the expertise and resources necessary to help clients deliver innovative gene therapies. Placed in the forefront of our leading, and innovative, Cell and Gene Therapy business enabling clients to cure genetic, rare, and otherwise untreatable diseases.

　　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 and this new team will be crucial 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, labeling and storage of samples where required as per material Specifications

　　Perform material transfer and gown into clean rooms

　　Perform equipment cleaning

　　Create purchase requests and ship raw materials for testing to external/internal laboratories

　　Reconcile test results for release of GMP materials

　　Identify, advance, 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 and governing SOPs

　　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

　　Review and author SOP and related documents

　　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 thirty (30) 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+ years’ experience in the pharmaceutical industry or related GMP environment.

　　Associate degree with experience in lab operations (Pharmaceutical environment preferred) and a solid understanding 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 temperatureIncredible Benefits:

　　· Medical, Dental, & Vision benefits – Effective Day 1

　　· Paid Time Off & Holidays

　　· 401K Company Match up to 6%

　　· Tuition Reimbursement – Available after 90 Days!

　　· Employee Referral Bonus

　　· Employee Discount Program

　　· Employee Recognition Program

　　· Charitable Gift Matching

　　· Company Paid Parental Leave

　　· Career Advancement Opportunities

　　At Thermo Fisher Scientific, each one of our 100,000+ extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

　　Apply today! http://jobs.thermofisher.com

　　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.

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　　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.