Job Description Help for Job Description. Opens a new window. Main Responsibilities Partner with Quality Assurance and Document Control teams to manage controlled documents. Maintain electronic and physical document control systems, ensuring proper versioning, access, and security. Receive, log, and organize all incoming and outgoing documentation related to production, quality, and regulatory processes. Prepare, review, and distribute controlled documents, including SOPs, batch records, and validation protocols. Support audits and inspections by providing accurate and timely retrieval of documentation. Track document revisions, approvals, and expiration dates to keep records current. Coordinate with cross-functional teams to facilitate timely submission, review, and approval of documents. Generate reports and metrics to support management oversight and quality monitoring. Ensure strict compliance with company policies, cGMP, FDA, and ISO requirements Job Requirements & Qualification Associates degree or higher in Life Sciences, Business Administration, or a related field. 2-5 years of experience in document control or clerical support in a regulated pharmaceutical or biotech environment. Knowledge of cGMP, FDA, and ISO documentation standards. Proficiency with electronic quality Management Systems (eQMS) and Microsoft Office Suite. Strong organizational skills, attention to detail, and ability to manage multiple priorities in a fast-paced environment.

Preferred:

Experience with eDMS platforms like QT9, Veeva Vault or MasterControl, exposure to regulatory submissions, validation documentation, or quality audits