Process and control the creation, revision, distribution, and archival of quality documents, including Standard Operating Procedures (SOPs), protocols, batch records, and reports.
Ensure all documentation complies with current Good Manufacturing Practices (cGMP), regulatory requirements, and internal policies.
Maintain the Document Control system, both electronic (e.g., eQMS) and paper-based.
Verify that controlled documents are reviewed, approved, and distributed in a timely manner.
Assist in managing document workflows, ensuring proper routing for approvals and signatures.
Perform periodic reviews of controlled documents to ensure they remain up to date and compliant.
Support the training of personnel on document control processes and the use of the Document Management System (DMS).
Serve as a point of contact for document control inquiries and troubleshooting.
Prepare and provide requested documentation during internal audits, client audits, and regulatory inspections.
Ensure timely and accurate retrieval of documents to support audit readiness.
Organize and maintain document archives in accordance with retention policies and regulatory requirements.
Ensure records are securely stored, easily retrievable, and safeguarded against unauthorized access or damage.
Identify opportunities to improve document control processes and implement enhancements to streamline workflows.
Stay current on industry standards and regulatory changes related to document management.
Qualifications:
Associate’s or Bachelor’s degree in life sciences, business, or a related field, or equivalent experience.
2+ years of experience in document control within a biopharma, CDMO, or regulated industry environment.
Familiarity with cGMP, FDA, EMA, and ISO documentation standards.
Strong attention to detail and organizational skills.
Proficiency in using electronic Document Management Systems (e.g., MasterControl, Veeva, or equivalent).
Excellent written and verbal communication skills.
Ability to handle multiple tasks and prioritize effectively in a fast-paced environment.
Analytical and problem-solving skills with a focus on accuracy and compliance.
