Job Description

As part of the Thermo Fisher Scientific team, you\xe2\x80\x99ll 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\xe2\x80\x99s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
Location/Division Specific Information This position will be site based in Plainville, MA and will support our Viral Vector Services (VVS Plainville) business unit of Thermo Fisher Scientific. At VVS Plainville, we deliver process development through commercial supply and offer the expertise and resources vital to help clients deliver innovative gene therapies. Placed in the forefront of our leading and cutting edge Cell and Gene Therapy business enabling clients to cure genetic, rare, and otherwise untreatable diseases. Schedule; Day Shift - 8am to 5pm Discover Impactful Work: The Quality Specialist I make an impact by participating in the day-to-day operations related to release functions in the Document control department. Ensuring documents meet company standards and regulatory requirements. Supporting Client and Regulatory Audits.
A Day in the Life:

• Document control activities related to document review, approval, and control.
• Supports all workflow types to support the business..
• Archives documents and manages document recalls from off-site storage.
• Make recommendations to operating departments on procedural or documentation related improvements.
• Assist with the improvement of quality compliance by recognizing continuing issues and bringing them to QA management\xe2\x80\x99s attention.
• Assist with mentoring document writers.
• Assist with maintenance of quality systems related to compliance, including but not limited to, deviations, quality investigations, environmental monitoring trending, and quality control activities.

Keys to Success:
Education

• BS degree required in science, or related field preferred.
• Experience with Documentum a plus.
• Experience working with quality systems related to compliance required.

Experience

• 2-3 years\' experience working in pharma, or other regulated industry.

Knowledge, Skills, Abilities

• Excellent written and oral communication skills.
• Strong analytical and problem-solving skills; great attention to detail and excellent decision-making process.
• Strong computer skills.
• Demonstrated ability to manage cross-functional teams and collaborate across the business.
• Must be proficient in Microsoft Office application.
• Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.

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 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! 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.