Job Title: QC Specialist I, Outsource Testing

Location: Cambridge, MA

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!

At Viral Vector Services (VVS) a division of Thermo Fisher Scientific, we offer the expertise and resources vital to help clients deliver innovative gene therapies. We are placed at the forefront of the Cell and Gene Therapy field, and we enable our clients to cure genetic, rare, and otherwise untreatable diseases!

How you will make an impact.

This specialist role coordinates all aspects of outsourced testing activities to support ongoing product release at the VVS Cambridge site. The specialist role will work closely with external vendors, customers and internal departments to ensure on-time completion of testing activities.

What will you do?

• Communicate daily with contract organizations- initiating new project conversations, negotiations, tracking timelines, test statuses, forecasting.
• Communicate daily with external and internal stake holders involved in the manufacturing process, including PM, MST, MFG, Supply Chain, QA, Regulatory and Quality.
• Track all samples submitted to QC outsourcing testing
• As needed, ensure the log books and relevant chain of custody forms are appropriately filled when samples are received or shipped.
• Schedule and coordinate with VVS Shipping/Receiving team the samples shipment/receipt of outsourced test samples (including filling out appropriate shipping request), in a timely manner.
• Review all incoming data from external test labs and submitting it for QC /QA approval per current, effective version of SOPs.
• Initiate, author protocol and coordinate stability protocol testing related to product stability projects in alignment with current effective version of SOP and regulatory guidelines.
• Develop and maintain appropriate tracking tools for various project testing’s and stability program.
• Be willing to get familiarized and keep updated with regulatory guidelines (ICH/compendial) associated with release and stability testing.
• Document work clearly, accurately, and in accordance with current, effective versions of relevant SOPs; Initiate deviations/CAPA measures as needed, in compliance with current, effective versions of SOPs.
• Participate and take lead in authoring/revising SOPs.
• Complete projects assigned by determined deadlines. Able to multi-task efficiently to ensure timely project completion.
• Assist management in evaluating and implementing new techniques and technologies with guidance.
• Work with the reporting Manager to improve and develop outsource testing and stability program functional group.
• Mentor junior staff.
• Miscellaneous tasks as necessary.

How will you get here?

• Bachelor’s degree in a scientific/technical subject area or related field
• Preferable, 1+ years’ experience in GxP setting

Knowledge, Skills, Abilities

• At least 0-3 years of related experience or equivalent combination of education & experience.
• Experience with LIMs preferred
• Experience working in and familiarity with cGMP Part 210, 211,11 and other relevant guidelines preferred
• Knowledge of Quality control testing as it pertains to regulatory, compendial and ICH guidelines preferred
• Strong interpersonal and communications skills; written and oral.
• Laboratory documentation review and revision experience.

Monday – Friday, Day Shift

At Thermo Fisher Scientific, each one of our 75,000 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.