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Quality Specialist II- Batch Record Review

Company: Thermo Fisher Scientific
Location: Cambridge
Posted on: November 22, 2021

Job Description:

Job Description :Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $35 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 90,000 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 Location/Division Specific InformationThis position reports into the Cambridge, MA site of Viral Vector Services (VVS) and reports to the Manager QA Operations, Batch Record Review

Mon - Fri 8am - 5pm (flexible)How will you make an impact?The Quality Specialist II, Batch Record Review will be the primary point of contact for the customer on all matters related to batch record review. 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 environment. The individual will perform activities in support of dispositioning product 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. Responsible for reviewing and approving batch records to support dispositioning of product. 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 deviations, CAPAs, change controls, and documentation issuance. This role will:

  • Review and approve batch records and supporting manufacturing documentation
  • Coordinate closure of GMP documents to support batch record closure and lot disposition
  • Provide quality support for manufacturing operations
  • Participate in deviation, CAPA, change control, and documentation activities, as needed
  • Identifying and implement continuous initiatives
  • Provide SME support for regulatory inspection
  • Ensure all quality related activities are performed
  • Resolve Quality related issuesHow will you get here?
    • Bachelor's Degree in Sciences and minimum 4+ 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 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
    • Experience with manufacturing operations is a plusPHYSICAL DEMANDS/FACTORS:
      • Ability to function in a rapidly changing environment & handle multiple priorities.
      • A flexible work schedule is required.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 90,000 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.comThermo 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.

Keywords: Thermo Fisher Scientific, Cambridge , Quality Specialist II- Batch Record Review, Other , Cambridge, Massachusetts

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