Duration: 4–6 months
Start Date: October
Overview:
Client is seeking a QA Documentation Consultant to support the Quality team. The consultant will manage the documentation control system, with responsibility for document requests, creation, change management, and archival processes. This role is not regulatory-facing but will play a critical part in supporting upcoming IND build by managing the established documentation master list and ensuring project deliverables remain on track.
Job Description:
QA Documentation Consultant to manage document control system, including creation, requests, changes, archival, and revision control. Support IND build by managing established master documentation list, tracking deliverables, and providing project management follow-up with stakeholders. Approve select documentation from CMOs, though not acting as SME or requiring full GMP/scientific expertise. Role integrates into the QA team (reporting to Sr. Director of QA) and requires independence, strong organizational skills, and at least 4 years of QA documentation experience at Sr. Associate level.
Responsibilities:
- Manage the Document Control system, including new document creation, document requests, revisions, and archival.
- Oversee document lifecycle management with a focus on revision control and compliance with established processes.
- Support the IND build process by managing and tracking the master documentation list, following up with stakeholders to ensure timely completion.
- Provide project management support to ensure documentation deliverables are met.
- Review and verify quality documentation; perform straightforward QA verification tasks as required.
- Approve certain documentation (e.g., from CMOs) where applicable, though not acting as SME or requiring deep scientific/GMP expertise.
- Collaborate with the Quality team (Sr. Director of QA and Documentation staff) to ensure alignment and integration.
Qualifications:
- Bachelor’s degree in a scientific or technical discipline preferred.
- Minimum 4 years of QA documentation experience in the pharmaceutical/biotech industry.
- Experience as at least a Sr. Associate level in Quality/Documentation.
- Strong understanding of documentation systems, quality data verification, and document lifecycle processes.
- Ability to work independently while being an integrated part of the Quality team.
- Excellent organizational and follow-up skills with a project management mindset.
- Strong communication skills and ability to interact with cross-functional teams.
Additional Details:
- Workload is part-time (~25 hours/week).
- Fully onsite role with flexibility (2–3 days per week required onsite).
MA: QA Doc Consultant (238117)
#LI-Onsite