Senior Quality Assurance Specialist

Responsibilities: Sustain an effective Sponsor training program Ensure current, controlled Sponsor documentation is accessible to site personnel Offer advice, guidance, and training to PET personnel on various documents and change controls Interact with Sponsors and Project Managers to address needs Develop and implement procedures/protocols for training, document control, and change control related to Sponsor Assure PET manufacturing sites have sufficient supply of approved labels/labeling to meet schedules Evaluate document change requests to identify potential Sponsor impact Support technology transfer of Sponsor drug products to Cardinal Health by leveraging compliance, quality, and training Collaborate to meet deadlines and stay compliant per Sponsor NDA's/IND's Interact with regulatory agencies and/or sponsor visits as necessary Identify opportunities to enhance efficiency Ensure positive Sponsor experience; commit to meet or exceed expectations Qualifications: Bachelors in related field, or equivalent work experience, preferred 4 years' experience in related field, preferred Experience working with Contract Manufacturers (CMO) PET Quality Experience, preferred Understanding of Quality Agreements, preferred 50% travel required; flexibility with travel including short notice