We have a current opportunity for a QA Associate Document Control for a rapidly growing biotech organization. The position will be based in Broward County and is a full-time direct hire role. For further information about this position please see the below and apply in.
Key Responsibilities
- Manage the document control system for GxP documents.
- Create batch records and related manufacturing documentation.
- Assess manufacturing discrepancies for deviation investigations.
- Oversee line clearance by reviewing cleaning and calibration records.
- Ensure materials and in-process products are approved for use.
- Review line clearance, delivery, and production logbooks.
- Support quality monitoring, sampling, inspections, and line clearance.
- Update SOPs to support batch record readiness and quality functions.
- Manage raw material/component release documentation for traceability.
- Ensure site compliance with internal procedures, cGMPs, and regulations.
- Review records for cGMP compliance and good documentation practices.
- Maintain record file systems and support the Quality Management System.
- Generate product labeling for manufacturing.
- Maintain a safe, compliant, and clean work environment, reporting issues to supervisors.
- Collaborate with Quality and production teams to resolve issues and maintain standards.
Key Qualifications
- Minimum of a year of experience in a GMP environment with quality systems experience.
- Must have experience in the pharmaceutical or biotech industry, or a regulated environment.
- Must have prior experience with a quality systems computer application.
