Document Control Support Specialist

Overview:

TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to clients worldwide. The job opportunity below is with one of our clients specializing in biotechnology product development services. The client is dedicated to supplying laboratory equipment, chemicals, supplies, and services essential in healthcare, scientific research, safety, and education. As a global leader in serving the scientific community, the organization generates approximately $40 billion in annual revenue and is committed to making the world healthier, cleaner, and safer. Their global team delivers innovative technologies, convenient procurement solutions, and pharmaceutical services through industry-leading brands.

Position: Document Control Support Specialist



Location: Plainville MA 02762



Duration: 12 Months



Job Type: Temporary Assignment



Work Type: Onsite

Shift: Monday To Friday From 08:00 AM To 04:30 PM/ 05:00PM

Summary

Document Control Specialist responsible for managing GMP documentation and supporting document review, approval, release, control, scanning, archiving, and database activities. The role requires experience in a GMP-regulated environment, strong Microsoft 365 skills, excellent organization, attention to detail, compliance orientation, and the ability to work effectively under pressure. The position supports Viral Vector Services (VVS) at the Plainville site within Client and contributes to maintaining quality and regulatory compliance.

Responsibilities

• Perform document control activities related to document review, approval, release, and control.
• Support daily document release functions within the Document Control department.
• Ensure documents meet company standards and regulatory requirements.
• Support various workflow types to meet business needs.
• Release GMP documentation and maintain controlled records.
• Create and maintain logbooks.
• Scan, archive, and upload documents to databases.
• Manage document recalls from off-site storage.
• Recommend procedural and documentation improvements to operating departments.
• Identify recurring compliance issues and communicate them to QA management.
• Assist with mentoring document writers.
• Support maintenance of quality systems related to compliance.
• Assist with deviations, quality investigations, environmental monitoring trending, and quality control activities.
• Collaborate with cross-functional teams across the business.

Required Skills

• 3 4 years of experience in a GMP-regulated environment.
• Associate degree in science or comparable work experience.
• Excellent written and verbal communication skills.
• Strong analytical and problem-solving abilities.
• Excellent attention to detail and decision-making skills.
• Excellent to advanced Microsoft 365/Microsoft Office proficiency.
• Strong computer skills.
• Excellent organizational and time-management skills.
• Ability to work effectively under pressure and manage multiple priorities.
• Strong compliance-oriented mindset.
• Ability to manage and collaborate with cross-functional teams.
• Ability to read and interpret safety rules, operating and maintenance instructions, and procedure manuals.
• Ability to recognize recurring quality/compliance issues and escalate appropriately.
• Experience with Documentum is a plus.

TekWissen Group is an equal opportunity employer supporting workforce diversity.