What are the responsibilities and job description for the Quality Assurance Specialist position at Actalent?
**About Actalent**
We are a global leader in engineering and sciences services and talent solutions.
Our mission is to advance our clients' engineering and science initiatives through access to specialized experts who drive scale, innovation, and speed to market.
**Job Overview**
This role involves ensuring compliance with regulatory requirements for all aspects of pre-clinical, clinical, and commercial manufacturing.
You will be responsible for reading, understanding, and following relevant documentation, including SOPs, WIs, and logbooks.
Additionally, you will perform raw material inspections, accession incoming apheresis, and conduct line clearance prior to manufacturing operations.
Compliance with FDA and Worldwide Quality & Compliance regulations as applicable to the job function is also essential.
**Responsibilities:**
- Maintain 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.
- Issue and maintain cGMP and cGTP documentation, including logbooks and training binders.
- Accessioning of incoming apheresis.
- Conduct line clearance prior to manufacturing operations.
- Compliance with FDA and Worldwide Quality & Compliance regulations as applicable to the job function.
- Review QC data.
- Material releases.
- Final product releases.
**Requirements:**
- Quality assurance experience.
- cGMP and cGTP knowledge.
- Raw material inspection skills.
- Issuance of batch records.
- Accessioning of incoming apheresis.
- Line clearance.
- Compliance with FDA and Worldwide Quality & Compliance regulations.
- Document management.
- Team-oriented.
- Attention to detail.
- Compliance-focused.
