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Job DescriptionAt Thermo Fisher Scientific team, you’ll discover impactful work, innovative thinking and a culture dedicated to working the right way, for the right reasons - with the customer always top of mind. The work we do matters, like helping customers find cures for cancer, protecting the environment, making sure our food is safe and delivering COVID-19 solutions. As the world leader in serving science, with the largest investment in R&D in the industry, our colleagues are empowered to realize their full potential as part of a fast-growing, global organization that values passion and unique contributions. Our commitment to our colleagues across the globe is to provide the resources and opportunities they need to make a difference in our world while building a fulfilling career with us.Location/Division Specific InformationAt the Plainville site within the Viral Vector Services (VVS), a division of Thermo Fisher Scientific, we deliver Advanced Therapeutics from process development through commercial supply, and we offer the expertise and resources vital to help clients deliver innovative gene therapies.Discover Impactful Work:This quality role will lead, as applicable, multi-disciplinary teams to provide support for implementation of quality key elements including transformative training, digitial drive, driving toward right first time and QMS simplification.A day in the Life:
Interface between with site resources to implement key systems and maintain them in a state of compliance.
Drive improvements to the methodology by which users engage with the Quality Management System Elements
Participates in Change Control, CAPA and deviation meetings, Risk Management teams, as required to define and assess actions required to support change management.
Generate and deliver content to support implementation and sustaining Quality Management Systems
Keys to Success:Education
A minimum of a Bachelor’s Degree is required in Chemistry, Life Sciences or Engineering.
Experience
At least 5 years of experience a GMP regulated industry is preferred (ie biotech, pharmaceutical, or medical device)
1 years minimum experience in knowledge management/sharing
Experience in working with internal and external partners to assure compliance, remediation of issues and continuous improvement.
Confirmed project management skills
Experience with key elements of the Quality system including deviations, CAPA, and client/regulatory audits.
Experience in writing, reviewing and approving GMP materials.
Knowledge, Skills, Abilities
Ability to work effectively across sites and partner with key internal team members.
Effective interpersonal and presentation skills.
Effective oral and written communication skills
Effective analytical and organizational skills.
Ability to multi-task and succeed in a fast-paced environment.
Strong time management skills and the ability work well in teams.
Physical Requirements / Work EnvironmentThis on-site position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; may be required to gown into cleanrooms and laboratories.BenefitsWe offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!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 (https://jobs.thermofisher.com/global/en/5-reasons-to-work-at-thermo-fisher-scientific) . As one 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.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.Accessibility/Disability AccessJob 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.
Vacancy expired!