Thermo Fisher Scientific Manager, QC Raw Material Sampling and Release in Cambridge, Massachusetts
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 cutting-edge Cell and Gene Therapy business enabling clients to cure genetic, rare, and otherwise untreatable diseases.
How will you make an impact?
This manager will lead the daily operations of VVS QC Raw Materials (QCRM) group located in Somerville, MA. This manager will lead 6-8 Quality staff members across two shifts. This manager will partner cross-functionally to support new product introduction teams, raw material qualification and other material related improvement projects. This manager will provide the primary oversight for contract testing labs that perform raw material release testing for VVS.
What will you do?
Hire, manage and develop team members within the QCRM group.
Determine and communicate inspection, sampling and release priorities, and distributes work assignments to staff.
Ensures that all raw material quality activities are performed in timely and compliant manner and are reviewed for accuracy.
Represent QCRM as required on new product introduction teams and other project teams to assure QCRM requirements are understood and timelines are met to support team goals. Assure any significant QCRM issues are communicated to key stakeholders in a timely manner.
This individual will partner with contract testing labs to establish testing methods, investigate and resolve issues, including out-of-specification (OOS) investigations related to the testing of Brammer materials.
Own and improve QCRM processes, related procedures (SOP) and forms. Support the improvement of other BIO5 procedures and processes.
Own or support the investigation of non-conformances in compliance with quality procedures, policies and regulations. Also manage quality records in other quality systems such as CAPA and change control.
Manage team performance by providing feedback, coaching and when required, actively manage performance issues.
Ensures adequate training (skills-based, cGMP and Safety) of QCRM team members to assure that they are qualified to perform their specific job responsibilities.
Responsibilities will also include execution of audit readiness activities and active participation in internal, client and regulatory audits, including presentation during the audit tours.
Ensures all testing processes, monitoring and departmental documentation meet Brammer Bio and cGMP regulatory standards.
How will you get here?
- BS in Chemistry, Microbiology, Biology or related technical field - preferred. A combination of education and experience will be considered. HS Diploma or equivalent - required.
At least 8 years of experience in regulated QC or Manufacturing operations.
Minimum of 3 years of leadership experience in GMP operations.Knowledge, Skills, Abilities
Knowledge of basic principles of chemistry, microbiology and quality control practices.
Demonstrated ability to plan, organize and lead Quality colleagues in a fast-paced operations environment.
Advanced knowledge of QC testing principles/procedures and laboratory documentation review.
Experienced in key Quality system processes including deviations, CAPA, OOS and change control.
Possesses good problem-solving skills with ability to defines complex issues.
Ability to communicate, written and oral, to internal partners and management, and externally to clients and contract labs.
Experience with process performance measurement and continuous improvement methodologies (Six Sigma, OPEX, etc.).
Knowledge of testing and associated equipment protocols and requirements and applicable instrumentation and procedures.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.
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 .
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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