We are currently engaged with a high growth biotechnology organization that specializes in Gene Therapy. They are currently in search of a Sr. Quality Assurance Specialist to take responsibility for identifying strategies, tactics, and objectives for product quality and GMP compliance.
The ideal candidate is an individual who can take initiative in building out their manufacturing process and work alongside many different departments within the organization. This person should be prepared to wear many hats and think on their feet as this is a high growth organization. This candidate will be tasked with conducting both internal and external audits and must have working knowledge of government regulations, cGMP and guidelines.
- Be able to vet and qualify new suppliers as well as the ability to perform external audits on vendors and suppliers
- Successfully drive the implementation of the new QMS system on the manufacturing floor collaborating with all departments at the site
- Extensive experience performing internal audits in GMP and hold teams accountable to world-class quality standards
- Strong writing and communication skills. Be prepared to review, approve, write, and revise Standard Operating Procedures
- Be able to provide mentorship and coaching. Guide, lead, and provide guidance/instruction to less senior members of the team
- A problem solver. Be prepared to manage and track corrective actions (CAPA’s) and product complaint systems
- Has working knowledge of cGMP and having additional experience in GCP or GLP would be preferred