What are the responsibilities and job description for the QA Documentation Specialist position at Pioneer GMP Consulting?
About the Role
Pioneer GMP Consulting is seeking a QA Documentation Specialist to support quality operations for a major biopharmaceutical manufacturing client in Worcester, MA.
This role focuses on controlled document management within a GMP-regulated environment, including SOP lifecycle management, quality record reviews, QMS workflow oversight, and documentation-related metrics reporting. The ideal candidate is highly detail-oriented, experienced with electronic Quality Management Systems, and comfortable working in a fast-paced, compliance-driven setting.
Lear more about the role here: Candidate Deck - QA Documentation Specialist
Key Responsibilities
- Manage SOP and controlled document lifecycle activities, including drafting, revising, formatting, routing, and approval coordination.
- Maintain accurate records in the site’s Quality Management System, ensuring all documentation meets internal and regulatory requirements.
- Monitor documentation workflows and follow up with stakeholders to ensure timely completion.
- Generate, track, and report quality metrics related to documentation performance and compliance.
- Support audit readiness by maintaining organized, complete, and accessible quality documentation.
- Collaborate with QA, Operations, and cross-functional partners to resolve documentation issues or discrepancies.
- Ensure adherence to GDocP, data integrity expectations, and established quality standards across all documentation activities.
- Identify process or documentation gaps and recommend improvements to enhance clarity, accuracy, and efficiency.
What We’re Looking For
Required Qualifications
- BS or AS degree
- 1–5 years of hands-on QA Documentation, Document Control, or Quality Systems experience in GMP pharma, biotech, or medtech industries.
- Experience managing controlled documents within an electronic QMS (Veeva preferred)
- Strong organizational skills and exceptional attention to detail
- Ability to review documentation for completeness, accuracy, formatting consistency, and compliance
- Familiarity with GMP, data integrity principles, and documentation standards (GDocP)
- Excellent written communication skills
- Ability to work onsite during normal business hours
- Comfort working independently and in a client-facing environment
- Interest in consulting or prior consulting experience, with the ability to adapt quickly, communicate professionally, and support multiple stakeholders
Nice-to-Have
- Experience supporting QA operations in a manufacturing environment
- Background in SOP authorship, document formatting, or technical documentation support
- Understanding of quality metrics, workflow management, or audit readiness activities
Key Soft Skills
- Confident and polished in client-facing settings
- Strong ability to influence and coordinate without formal authority
- Friendly, professional communication style suited for cross-functional interactions
- Highly organized, reliable, and consistent in follow-through
- Comfortable collaborating with multiple departments and stakeholders
- Detail-oriented with strong ownership of accuracy and compliance
- Proactive in identifying gaps, following up, and keeping workflows on track
- Adaptable and steady in fast-paced, changing environments