Thermo Fisher Scientific QA Operations Specialist III 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. 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 .
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 III 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 and leading initiatives 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.
Provide on the floor support for manufacturing operations
Participate in deviation and investigation activities
Identifying and implement continuous initiatives
Train junior staff on QA function
Provide SME support for regulatory inspection
Ensure all quality related activities are performed
Delegate 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?
Bachelor's Degree in Sciences and minimum 5 to 8 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.
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.
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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