The QA Document Control Associate supports departmental operations by assisting customers with document revision and internal/external document requests.

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required to perform this job safely. Other duties, responsibilities and activities may change or be assigned at any time with or without notice.

EDUCATION AND/OR EXPERIENCE

• B.A. or B.S. degree (preferably in Life Science).
• Minimum of 1 -3 years of experience in the biopharmaceutical industry.

• Support departmental operations by assisting customers with document revisions and internal/external document requests.
• Collaborate cross-functionally to ensure timely and effective execution of document review activities.
• Proficiency with the ComplianceWire electronic training system, including tasks such as assigning curricula, generating training reports, and creating or revising curricula.Issue and reconcile equipment logbooks, laboratory notebooks, and controlled documents (e.g., SOPs, forms, and logs).
• Maintain and organize documents within the QA archive; retrieve archived documents upon request.
• Uphold GMP standards and QA policies, including adherence to Good Documentation Practices (GDP).
• Assist in maintaining inspection readiness and provide support during regulatory and other audits.
• Perform additional duties as assigned by Quality Management.