Thermo Fisher Scientific Specialist II, QA Ops 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 reports into the Cambridge, MA site of Viral Vector Services (VVS) and reports to the QA Ops Supervisor.
How will you make an impact?
The Quality Assurance Specialist II will be the primary point of contact for the customer on all matters related Quality Assurance Operations. This position requires a highly motivated, tenacious, self-starter who can assimilate new information quickly and enjoys working closely with others within a fast-paced project execution environment. The individual will perform activities in support of dispositioning product and/or raw materials while ensuring compliance with VVS directives and procedures, customer requirements, and regulatory standards.
What will you do?
Responsible for contributing to key functional, tactical, and operational aspects of VVS operations at the Cambridge site. This includes approval & oversight of MFG and QC activities associated with exceptions, CAPA, deviations, Analytical instrument validation, change control requests, and other documentation related to Mfg and QA operations. Responsible for evaluating impact, ensuring adherence to compliance standards, including technical ability to evaluate & approve these quality system elements, as delegated by management. Additional responsibilities may include support in personnel interviewing/training, compliance with policies & inspections. Provides feedback for personnel development.
Coordinate inputs from clients and Quality Operations functional team from work statement approval through to project completion.
Ensure timely awareness of quality agreements to key functional representatives and Quality Operations function
Ensure alignment with Quality Agreements
Attend and participate in client meetings, Tech Transfers, and other related meetings in support of client projects.
Ensure all quality related activities are performed
Deligate tasks within the Quality Operations function and drive progress to completion during execution to the required standard (internal and customer's) and ensure on-time completion of Quality deliverables
Resolve Quality related issues How will you get here? Education/Knowledge/Experience
Bachelor's Degree in Sciences and minimum 5 years' Quality related experience
Solid understanding of US, EU and ROW cGMP guidelines and requirements.
Ability to recognize, understand and respond to situations requiring further evaluation and report these events (process, safety, personnel, etc..) to senior specialists or area management.
Strong analytical and problem-solving skills coupled with the ability to work both independently and in a team environment
Ability to understand operational documents for GMP compliance, accuracy and completeness. Ability to work by influencing a matrix management system and to gain the cooperation of others.
Strong client-facing interpersonal skills coupled with a concern for impact.
Strong time management and organizational skills.
Excellent written and oral communication skills both internal and external.
Able to manage multiple priorities and demonstrate self-control
Ability to resolve conflict within project teams.
Good leadership skills.
Strong attention to detail
Strong interpersonal and communication skills and the ability to work effectively with a wide range of constituencies in a diverse community.
Ability to function in a rapidly changing environment & handle multiple priorities. A flexible work schedule is required. Ability to lift up to 25 lbs. Specific vision abilities required by this job include close vision, and ability to adjust focus.
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 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. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.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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