What are the responsibilities and job description for the Regulatory Compliance Associate position at Actalent?
**About Actalent**
We are a global engineering and sciences services and talent solutions company.
Actalent helps visionary companies advance their engineering and science initiatives through access to specialized experts.
**Job Description**
As a Quality Assurance Associate II, you will play a critical role in ensuring the quality and compliance of our products.
Key responsibilities include performing raw material inspections, accessioning incoming apheresis, and conducting line clearance prior to manufacturing operations.
Additionally, you will be responsible for maintaining compliance with FDA and Worldwide Quality & Compliance regulations as applicable to the job function.
**Responsibilities:**
- Ensure cGMP and cGTP compliance for all aspects of pre-clinical, clinical, and commercial manufacturing.
- Perform raw material inspections and release according to SOPs and in compliance with regulatory standards.
- Maintain accurate and complete documentation, including logbooks and training binders.
- Accession incoming apheresis.
- Clear lines prior to manufacturing operations.
- Comply with FDA and Worldwide Quality & Compliance regulations as applicable to the job function.
- Review QC data.
- Release materials and final products.
**Requirements:**
- Quality assurance expertise.
- cGMP and cGTP knowledge.
- Raw material inspection skills.
- Batch record issuance.
- Accessioning of incoming apheresis.
- Line clearance.
- Compliance with FDA and Worldwide Quality & Compliance regulations.
- Document management.
- Team-oriented.
- Attention to detail.
- Compliance-focused.
