Innovating every day.™

Basic Purpose:The Senior Specialist, Quality Assurance is responsible for obtaining technical documentation from suppliers and administering the Supplier Audit database. The role will coordinate quality agreements, audits and risk assessments for API/Excipient manufacturers, contract laboratories, packaging suppliers and 3rd party contract manufacturers. This position will also provide assistance with review and approval of documentation from 3rd party contract manufacturers (batch records, deviations, CAPAs, process validations, etc.) and assist the Director in monitoring and providing quality metrics to senior management.Essential Functions and Responsibilities• Responsible for reviewing technical documents for 3rd party contract manufacturers. Technical documents include batch records, deviations/CAPAs, process validations, specifications, etc. • Administers the Supplier Audit database and associated documents. Assists with performing supplier audits, risk assessments and maintaining audit schedules. • Administers the CAPA system focusing on PA approval, closure and database tracking.• Work with all levels of management to resolve issues discovered during review and participate in the problem-solving process.• Partner with Supply Chain, R&D and Quality to obtain required supplier documentation to support qualification and risk assessment.• Researches and prepares data needed for monthly quality metrics reporting to senior management.• Other duties as assigned by managementEducation/Training/Work Experience• BS degree in analytical field of study.• Five plus years relevant experience in a pharmaceutical/industrial experienceSpecialized Knowledge and Skills• Strong technical writing and documentation review skills.• Strong interpersonal and team building skills.• Familiarity with current regulatory trends and knowledge of current cGMP's• Good organization, documentation and communication skills• Attention to detail, strong technical skills.• Strong working knowledge of PCs and Microsoft applications.
• Experience with Trackwise preferred