Specialist I - Quality Assurance

About the role

Accountable for the compliance and effectiveness of the Supplier and Material Quality Assurance programs. Manages and maintains the quality Approved Supplier List. Schedule and conduct audits of suppliers and vendors in accordance with site policies and procedures. Evaluate audit results and follow up on any outstanding issues/actions. Leverage audits performed by sister Catalent sites. Responsible for collaboration with Catalent sister sites and suppliers to draft and maintain Quality Agreements. Responsible for collaboration with internal Catalent stakeholders to support the Supplier Quality Assurance team in leading corrective action associated with material and supplier quality issues. Provides support for the introduction of materials from new suppliers and material qualification program. Develop and conduct training to support consistent and accurate execution of the supplier and material quality controls. Files and maintains controlled documents. Other duties as assigned. The Candidate: Doctorate Degree in STEM discipline with minimum of 0 years related experience. OR Master's Degree in STEM discipline with minimum of 4 years related experience. OR Bachelor's Degree in STEM discipline with minimum of 6 years related experience. OR Associates Degree in STEM discipline with minimum of 10 years related experience. Ability to use Excel, Word, and other office systems. Prior work experience with quality management software such as TrackWise® or ComplianceWire®. Ability to independently apply CGMPs to everyday work. Maintains data integrity and ensures compliance with company SOPs and specifications as well as cGMP, ICH, FDA, EMA regulations or guidelines. Executes procedures of high complexity with high quality. Advanced understanding of pharmaceutical laboratory and/or production operations. Why you should join Catalent: Defined career path and annual performance review and feedback process Diverse, inclusive culture Positive working environment focusing on continually improving processes to remain innovative Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives 152 hours of PTO + 8 paid holidays Generous 401K match Medical, dental and vision benefits effective day one of employment Tuition Reimbursement - Let us help you finish your degree or start a new degree! Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of a