Document Control Support Specialist

TekWissen • Plainville, MA

1d • Onsite

About The Position

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. This position supports Viral Vector Services (VVS) at the Plainville site within Client and contributes to maintaining quality and regulatory compliance.

Requirements

• 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.

Nice To Haves

• Experience with Documentum is a plus.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree