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Quality Documentation Specialist
Job Location:
Job Location:
Portsmouth, OH - USA
Monthly Salary:
Not provided by the employer
Monthly Salary:
Posted:
10 June 2026 (30+ days ago)
Posted:
Application Deadline:
7 September 2026
Application Deadline:
Vacancies:
1 Vacancy
Vacancies:
Job Summary
Overview:
TekWissen is a global workforce management provider headquartered in Ann Arbor Michigan that offers strategic talent solutions to our clients world-wide. Our client is a leading biotechnology company that combines technological insight with world-class manufacturing scientific expertise and process excellence and helps their customers to deliver new and innovative medicines that help treat a wide range of diseases. Our client specializes in pharmaceutical ingredients Bioscience Biopharmaceuticals Custom manufacturing Biotechnology Life science ingredients Nutrition Microbial Control Agriculture Materials Science Personal Care and cell and gene therapy.
Job Title: Quality Documentation Specialist
Location: Portsmouth NH - 03801
Duration: 6 Months
Job Type: Temporary Assignment
Work Type: Onsite
Shift: Monday to Friday from 08:00 AM to 05:00 PM
Summary:
The Quality Systems Support Specialist / Quality Documentation Specialist is responsible for supporting Quality System Management processes including document control and Pharmaceutical Quality System (PQS) integration. The role focuses on maintaining quality documentation within Veeva supporting document workflows and change control activities and ensuring compliance with cGMP and global quality requirements while maintaining inspection readiness.
Responsibilities
- Support the implementation execution and maintenance of PQS integration and Quality Documents in Veeva at the Vacaville site.
- Collaborate with the Quality Document Control group to:
- Complete document workflows.
- Manage document gating activities.
- Coordinate document change control processes.
- Minimize disruption to site operations during document updates.
- Initiate and manage quality documents within Veeva Quality Docs.
- Format and edit controlled quality documents.
- Track and maintain logs of source document requests.
- Ensure all activities comply with cGMP and global quality requirements.
- Support and maintain a high level of inspection readiness.
- Work effectively with cross-functional teams to support quality system initiatives.
Required Skills & Qualifications
- A Bachelors or an AA degree
- 1 3 years of Quality experience within the pharmaceutical or biopharmaceutical industry.
- Experience supporting quality systems and document control processes.
- Supplier Quality experience is highly desired.
- Experience with document management and document control systems is required
- Experience with Veeva Quality Document Management System and Microsoft Teams
- Technical writing experience is huge plus.
- Experience managing controlled documents and document workflows.
- Knowledge of cGMP requirements.
- Understanding of Pharmaceutical Quality Systems (PQS).
- Familiarity with quality documentation and change control processes.
- Knowledge of inspection readiness practices.
- Strong collaboration and teamwork skills.
- Ability to work effectively within diverse cross-functional teams.
- Strong organizational and documentation skills.
- Attention to detail.
- Ability to coordinate multiple document-related activities and priorities.
TekWissen Group is an equal opportunity employer supporting workforce diversity.
