Sr. QA Specialist
($95K-$105K/year)
This company is a pioneer in the cGMP production sector and is committed to developing gene therapy. Their goal is to create novel, secure, and efficient long-term treatments for illnesses by utilizing their expertise, resources, technology, and knowledge in the fields of translational and regulatory science. As they work to make a difference with every product and instill hope in the hearts of every patient and their family, there is no condition too uncommon or difficulty too great. The main idea of this biotech company is the full-service production of Adeno Associated Viruses (AAV). Every year, they collaborate with more than 100 clients to produce AAV at levels of development, toxicological, clinical, and commercial grade.
Duties and Responsibilities:
- Scheduling, preparing, and performing internal and external audits support of GMP
- Assembling and coordinating the activities of the audit team, if needed.
- Performing audits in accordance with the company's standard operating procedures, quality policies, GMP regulations.
- Escalating compliance issues, as needed. Communicating audit results to management and auditees through written audit reports.
- Leading post-audit activities, following up on vital corrective and preventive actions by resolving any issues.
- Assisting with hosting facility inspections by acting as ascribe and/or document reviewer, as needed.
- Drafting and issuing periodic reports to site management, as requested. Assignment, tracking and completion of CAPA activities associated with audits.
- Assisting with training/orientation for new Quality Auditing staff.
Knowledge, Skills, and Abilities Required
- BA with at least three years of related experience in Biotech/Pharmaceutical industry
- At least three years of audit experience in a GMP environment preferred.
- Detailed oriented; ability to track timelines and milestones.
- Negotiation skills and ability to communicate with all levels of an organization.
- Proficiency in developing and writing procedures, audit reports and corrective action plans.
- Experience in using Track wise is preferred.
- Ability to work with minimal supervision.
