Thermo Fisher Scientific Specialist I, QC Outsourcing in Cambridge, Massachusetts
When you're part of the team at Thermo Fisher Scientific, you'll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you'll be supported in achieving your career goals.
Location/Division Specific Information
This position will site at the 250 Binney Street, Cambridge, MA site of Viral Vector Services (VVS) and report into the QC Outsource Manager.
How will you make an impact?
Responsible for coordinating internal and external testing inclusive of raw materials, in-process & finished product, formulations and according to SOPs. Compiles data for documentation of test procedures, prepares reports. Provides QC input and support throughout VVS (e.g. projects, product transfers and inspections). Ensures all testing processes, monitoring, and departmental documentation meet VVS and cGMP regulatory standards. Contributes to the development of new concepts, techniques, and standards. Has an understanding and application of principles, concepts, practices and standards. Involved with sample control activities inclusive of sample submission, tracking and coordination. Assists in the preparation of CoAs.
What will you do?
Central Coordinator for all testing in Quality control. Work on projects independently with limited supervision.
Support multiple groups within QC and works closely with appropriate Manufacturing personnel to ensure timely resolution of issues. Perform all assays in support of manufacturing and critical utilities/environment per cGMP. Central point for sample submission, tracking and testing coordination.
Manage outsourced testing needs, timelines, risk mitigation and business priorities.
Frequent use & general knowledge of industry practices, techniques and standards. General application of concepts and principles.
Assist with developing solutions to variety of problems of moderate scope and complexity. Refers to policies and practices for guidance.
Review/analyze testing protocols generated by CTLs for cGMP production lots.
Author/revise SOPs, method development, and validation protocols/reports.
Develop, execute and ensure compliance to outsourced testing procedures.
Review deviations/ investigations from CTLs; prepare tandem in-house investigation/ deviation reports. Assist in developing metric parameters to evaluate and monitor performance of CTLs.
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.
Assist in the performance of quality audits of CTLs for compliance. Work closely with staff responsible for preparation and shipment of samples to CTLs to ensure timelines are met and samples are maintained in the appropriate condition.
Execute sample control activities per appropriate SOPs
Other duties as assigned.
How will you get here?
BS in Biological Science or related technical field
Minimum of 0-3 years of related experience or equivalent combination of education and experience.
Prior knowledge of QV testing principles and procedures as applicable to focus of position.
Exposure to cGMP environment
Knowledge of testing and associated equipment protocols and requirements and applicable instrumentation and procedures.
Laboratory documentation review and revision experience
Ability to function in a rapidly changing environment & handle multiple priorities
A flexible work schedule is required.
Ability to lift up to 25 lbs.
At Thermo Fisher Scientific, each one of our 70,000 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.
Note: This job description is not all-inclusive. Additional duties may be performed, as assigned. It acts as a guideline and is subject to change over time.
Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.
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