The Document Control Specialist will manage and coordinate critical cGMP documentation, procedures, and records that keep PCI's operations compliant and audit-ready.
Requirements
- High School/Associate degree with 10+ years in a cGMP environment, OR
- Bachelor’s degree with 5–10 years of relevant experience in pharma/biotech manufacturing.
- Strong organizational abilities
- MS Office proficiency
- Comfort working with SOPs and spreadsheets.
- Prior pharmaceutical GMP experience
- Experience supporting audits.
Responsibilities
- Maintain quality system databases, master documents, and numbering logs.
- Issue, archive, and manage controlled records (Batch Records, Lab Books, Log Books, Testing Data Sheets, etc.).
- Facilitate batch record creation, modifications, and approvals for client projects.
- Lead SOP lifecycle management including biennial reviews, updates, and obsoleting outdated versions.
- Write and develop QA SOPs; implement new systems for document control with minimal supervision.
- Proof, edit, and process document changes.
- Assist with audit preparation, reconciliation, and line clearances (as needed).
Other
- Excellent written/verbal communication
- Detail-oriented
- Adaptable
- Able to thrive in a fast-paced, team-oriented environment.
