Document control support specialist - united states, new bedford
the role is onsite, hours 7:30 - 4:00 or 8:00 to 4:30pm
location:
5 commerce boulevard
plainville, ma 02762
united states
at 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.
how will you make an impact?
the document control specialist will participate in the following:
• document control activities related to document review, approval, and control.
• participates in the day to day operations related to release functions in the document control department.
what will you do?
• ensures documents meet company standards and regulatory requirements
• supports all workflow types to support the business
• supports client and regulatory audits
• 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 managements 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.
how will you get here?
education
• associate degree in science
• minimum of three - four years of appropriate experience in gmp regulated environment.
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.
• experience with documentum a plus
comments
must be highly skilled in microsoft 365 (esp. word 365)
equal opportunity employer/veterans/disabled
the company will consider qualified applicants with arrest and conviction records
Apply to this job now Report abuse