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Catalent, Inc. is looking for a Supplier Quality Assurance Senior Specialist to manage and execute tasks that support the Global Comparator and Depot Supplier Quality Management and Clinical Packaging Network site Supplier Programs, ensuring compliance with national and international standards.

Requirements

• Prior Supplier Auditing experience and experience in writing supplier audit reports, certified auditor or lead auditor credentials are preferred
• Experience and sound knowledge of GMP/GDP/GCP regulations, especially those related to comparator sourcing, wholesaler licensing, third party storage and distribution preferred
• Prior experience in JDE and Trackwise systems preferred
• Demonstrate project management skills with an ability to prioritize, plan, evaluate & execute deliverables for established tactical goals

Responsibilities

• Manage the approved supplier list for Global Supplier Quality and network supplier programs
• Independently plan, conduct, review and report site and questionnaire audits including third-party and outsourced audits for new and existing domestic and international suppliers in line with Network procedures
• Ensure supplier records are initiated and maintained for all supplier approval documentation including audits, assessments, and quality agreements
• Complete Supplier Quality Agreements, Supplier Audits, (questionnaire and site), Risk Assessments, Risk Control Plans, License Review, Change Controls, Actions and Follow-up’s
• Evaluate and perform impact assessments and execute action plans for supplier change notifications (i.e. facility change, supplier change controls)
• Monitor/support supplier license renewal for applicable services
• Liaise with suppliers to ensure compliance to regulatory changes or updates (globally)

Other

• A High School Diploma or General Education Diploma with at least six years of experience in Quality or Pharmaceutical is required; A Bachelor’s Degree in a Scientific or Engineering discipline with at least three years of experience in pharmaceutical quality OR High School Diploma or General Education Diploma with at least five years experience in Quality auditing is required
• Position is site based and candidate must be able to commute to one of the Clinical packaging sites at Catalent located in the US region (San Diego, PHL or KCM)
• Ability to travel both domestic and abroad to Catalent sites or Catalent supplier locations as required ~25% travel
• On an average 8-hour day this position requires the ability to walk, sit and stand, use hands to handle or feel, reach with hands and arms at or above shoulder height and below waist height, climb or balance, stoop, kneel, crouch, or crawl; talk and hear, smell and lift up to 40 pounds. Specific vision requirements include reading of written documents, visual inspection of materials and use of computer monitor screen frequently