Job Title: Document Control Support Specialist
Location: Plainville, MA 02762 (Onsite)
Duration: 12 months W2 contract with high possibility of extension based on performance and depending on business needs.
Pay Range: $25 to $30/Hour on W2
Shift Timing: 8AM to 4:30PM EST
Job Summary:
Not looking for Tech Writers or Config Analysts
Must be highly skilled in Microsoft 365 (Word 365).
Must be highly focused on accuracy, reliability and the TFS corporate concept of right first time.
Must be able to be a backroom audit supporter.
Experience in a GMP environment, excellent to advanced Microsoft 365 skills, organization, works well under pressure, compliance oriented.
This person will spend their days releasing GMP documentation, creating logbooks and lots of scanning and archiving to databases.
At the Plainville site within the Viral Vector Services (VVS), a division of ***, 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
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 s 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 or comparable work history experience.
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