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Thermo Fisher Scientific Quality Assurance Specialist II, Nights 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.

Location/Division Specific Information

Cambridge, MA Nights 7P - 7A 2/2/3

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 CAPA, deviations, and other documentation related to MFG and QA operations. Additional responsibilities may include support in personnel interviewing/training, compliance with policies & inspections. Provides feedback for personnel development.

  • Batch Record/Logbook review

  • Document/Label Issuance and archival

  • Quality support for Critical MFG Operations on the floor

  • Initiation and approval of deviations through Trackwise

  • Participate in training of personnel

  • Mentor Junior Staff

  • Process improvement initiatives

  • Review and approve documents including: Standard Operating Procedures, Batch Records, Work Instructions.

  • Perform Acceptable Quality Limit (AQL) of Fill Finish vials

  • EM Data review for Room release

  • Support third party audits, external customers, and Agency inspections as needed and support internal activities concerning any identified nonconformities

How will you get here?

Education

  • BS - Required. Ideally in Life Sciences, Engineering or Manufacturing

Experience

  • Minimum 3 years Quality related experience

  • Solid understanding of US, EU and ROW cGMP guidelines and requirements.

Knowledge, Skills, Abilities

  • 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.

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 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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