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Thermo Fisher Scientific Compliance Specialist III, Technical Operations in Plainville, Massachusetts

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Viral Vector Services, a division of Thermo Fisher Scientific is a rapidly growing, dynamic gene therapy contract development and manufacturing organization that is seeking sharp individuals to bring the highest quality processes, products and testing to our clients. Our employees are committed to making a difference in our organization, for our client partners and the patients we serve.

As a member of Technical Operations you will join a passionate and welcoming team dedicated to the success of our clients and manufacturing partners. Our new best in class facility in Plainville, MA is an exciting place for those seeking to make an impact and grow in their careers!

How you will make an impact

In the MFG Compliance Specialist III role you will be part of a cohesive team responsible for Deviations, CAPAs, and Change Controls for all phases of manufacturing. The Manufacturing Specialist uses knowledge of cGMP regulations and project management to ensure manufacturing readiness. You will also support equipment, documentation, investigations, and improvement initiatives within the manufacturing operations. You will work independently with minimal supervision and direction. You will perform work that consistently requires independent decision making and the exercise of independent judgment and discretion.

What you will do

  • Lead deviation investigations and associated corrective and preventative actions in collaboration with QA and area SMEs

  • Support manufacturing at tech transfer with change controls

  • Support and develop consistent manufacturing/quality standards and/or process for Deviations, Change Controls, and CAPAs in Quality System

  • Perform training with staff for Deviations, Change Controls, and CAPAs as needed

  • Participate in initiatives to support, innovation and continuous improvement activities and improved compliance with quality procedures, policies and regulations

  • Participate in client and planning meetings as needed

  • Practice and promotes safe work habits and adheres to safety procedures and guidelines

How will you get here?

Education

  • Bachelors Degree highly desired with 3 years industry experience or at least a minimum of 5 years experience in pharmaceuticals manufacturing and/or quality

Experience

  • Experience leading investigations including knowledge of root cause tools

  • Experience using QA systems for electronic management of CAPAs and deviations

Knowledge, Skills, Abilities

  • Strong interpersonal and communication skills and the ability to work effectively with diverse teams

  • Able to make decisions and work with minimal to moderate supervision

  • Solid understanding of applicable cGMP regulatory requirements

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one global team of 100,000 colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

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.

Accessibility/Disability Access

Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.

*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.

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.

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