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QA Client Alliance Specialist III

Job in Cambridge - Middlesex County - MA Massachusetts - USA , 02138
Company: Thermo Fisher Scientific Inc.
Full Time position
Listed on 2021-04-15
Job specializations:
  • Quality Control
    QA Manager, Quality Assurance
  • Management
    Operations Manager
Job Description & How to Apply Below
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 reports into the Cambridge, MA site (250 Binney Street) of the Viral Vector Services Division (VVS) and reports to the QA Client Alliance Manager.

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 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
* Attend and participate in client meetings, Tech Transfers, and other related meetings in support of client projects.
* 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
* Maintain program metrics

How will you get here?

* 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

PHYSICAL DEMANDS/FACTORS:

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.

At Thermo Fisher Scientific, each one of our 75,000 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.
 
 
 
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