Job Description
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
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.
Numbers & Facts
| Location | Plainville, MA |
| Industry | Computer/IT Services |
| Salary | $28–$30 |
| Company Size | 100 to 499 employees |
| Year Founded | 2009 |
| Website | http://www.tekwissen.com/ |
About Company
WE THE TEKWISSEN PEOPLE
TekWissen offers you a broader portfolio of services, industry-leading solutions, and the meaningful innovations that give you greater flexibility and speed to respond to market dynamics, reduced costs and risk to improve enterprise performance, and increased productivity to enable growth.
To keep pace with global market demands, TekWissen keeps its finger on the pulse of change. Our organized approach to guiding a project from its inception to closure. Managing projects is becoming more and more important as we enter the digital era. To cope with the pace that this transition demands, a method is required to manage projects so they can yield quality work, while incorporating efficient use of time and resources.
Project involves identifying which quality standards are relevant to the project and determining how to satisfy them.
It is important to perform quality planning during the Planning Process and should be done alongside the other project planning processes because changes in the quality will likely require changes in the other planning processes, or the desired product quality may require a detailed risk analysis of an identified problem. It is important to remember that quality should be planned, designed, then built in, not added on after the fact.
Capabilities and accomplishments in one TekWissen business enhance the opportunity for success in the others. Put simply, TekWissen's unique combination of attributes promotes success.Skills
- Analysis Skillsunmatched
- Biotech and Pharmaceuticalunmatched
- Communication Skillsunmatched
- Computer Skillsunmatched
- Cross-Functionalunmatched
- Detail Orientedunmatched
- Diversityunmatched
- Document Controlunmatched
- Document Managementunmatched
- Documentationunmatched
- Documentation Reviewunmatched
- Documentum Enterprise Content Management (ECM) Systemunmatched
- Environmental Monitoringunmatched
- GMP (Good Manufacturing Practices)unmatched
- Healthcareunmatched
- Identify Issuesunmatched
- Laboratory Equipmentunmatched
- Maintain Complianceunmatched
- Mentoringunmatched
- Microsoft Officeunmatched
- Microsoft Product Familyunmatched
- Multitaskingunmatched
- Organizational Skillsunmatched
- Presentation/Verbal Skillsunmatched
- Problem Solving Skillsunmatched
- Procedure Developmentunmatched
- Product Developmentunmatched
- Purchasing/Procurementunmatched
- Quality Assuranceunmatched
- Quality Controlunmatched
- Quality Managementunmatched
- Record Keepingunmatched
- Scientific Researchunmatched
- Support Documentationunmatched
- Systems Maintenanceunmatched
- Technical Deliveryunmatched
- Time Managementunmatched
- Workforce Managementunmatched
- Writing Skillsunmatched
Level up your application
Professional resume templates
Browse dozens of recruiter approved resume templates, layouts and formats. Choose your favorite and make it your own in minutes.
Free resume templatesFree resume builder
Improve your existing resume or start from scratch and create a standout, ATS-friendly resume. Add job-specific content, download and apply.
Free resume builder