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Specialist I, Quality - Days

Company: Thermo Fisher Scientific
Location: Cambridge
Posted on: September 25, 2022

Job Description:

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 will site at the 250 Binney Street, Cambridge, MA site of Viral Vector Services (VVS) and report into the QA Operations Manager. Shift: 7AM - 7PM How will you make an impact? The Quality Assurance Specialist 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 Brammer Bio directives and procedures, customer requirements, and regulatory standards. Essential Responsibilities: --- Works within assigned QMS element(s) in accordance with process and procedural requirements. Coordinates and conducts information and training sessions applicable to their designated QMS element for associates, as necessary. PoC for monitoring and maintenance of activities associated with and Quality Records generated from their designated QMS element in accordance with process and procedural requirements and reports upward and outward accordingly. Participates in regulatory compliance audits and inspections. Coordinate meetings. Leads investigations, as necessary. Maintain basic quality and regulatory knowledge for Cell and Gene Therapy cGMPs and their designated QMS element. Assist in developing integrated implementation strategies for a variety of QMS elements. Review records and documents, for completeness and compliance with company and regulated requirements. Collaborate with other function teams to resolve record discrepancies or errors as it related to Good Documentation Practice. Assist to improve standard operating procedure and improve quality systems functions. May assist in interdepartmental initiatives for continuous improvement to processes and procedures. Provide guidance on general quality principles and specific procedural requirements. Perform and complete work with general supervision. --- Responsible for contributing to key functional, tactical, and operational aspects of Brammer Bio 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. --- Proficiency in project management, processes, improvement and ability to address through risk assessment. --- Additional responsibilities may include support in personnel interviewing/training, compliance with policies & inspections. --- Provides feedback for personnel development. Knowledge, Skill, and Requirements: --- High School Diploma with 4+ years exp or Bachelors degree in B.S. in Chem Eng, Biochemistry, Biology or related field; B.S. in Chem Eng, Biochemistry, Biology or related field --- 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. --- High initiative. --- Rational Persuasion --- Strong time management and organizational skills. --- Pragmatic, proactive yet flexible approach in the working environment. --- 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. --- proficient at public speaking, teaching, facilitating to peers, senior associates, and area management within their operational group. Physical Demands --- Ability to function in a rapidly changing environment & handle multiple priorities --- A flexible work schedule is required. --- Ability to lift up to 25 lbs. At Thermo Fisher Scientific, each one of our 100,000+ 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.

Keywords: Thermo Fisher Scientific, Cambridge , Specialist I, Quality - Days, Other , Cambridge, Massachusetts

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