Quality Assurance Specialist III

Responsibilities

• Review manufacturing documentation, including lot history records and non-conforming material reports, to ensure compliance with internal procedures
• Track documentation discrepancies and maintain mechanisms to identify trends
• Notify manufacturing personnel of documentation issues and provide formal feedback on discrepancies
• Manage the quarantine area for discrepant materials until resolution and release
• Perform SAP transactions in the sterile cycle to release products upon completion of LHR review
• Review and approve Design History Files (DHFs) and verify contents for Engineering Order authorization
• Act as a subject matter expert in documentation compliance for manufacturing and project leaders
• Coordinate the release of clinical products to approved sites through appropriate paperwork
• Audit materials and work processes via examination, inspection, and testing of raw materials and components

Requirements

• High School Diploma or GED (or equivalent combination of education and experience)
• Minimum 4 years of related work experience
• Solid knowledge of business concepts, procedures, and functional area fundamentals
• Ability to perform complex assignments in a quality system environment
• Demonstrated ability to use judgment, initiative, and leadership in troubleshooting and continuous quality improvement

Preferred Qualifications

• Associate's Degree or some college credits

Benefits

• Career development opportunities within an international company
• Eligibility for free medical coverage via the Health Investment Plan (HIP) PPO plan
• Retirement savings plan with high employer contribution
• Tuition reimbursement and student debt assistance programs
• Access to FreeU education benefits for bachelor's degrees

About the Company

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans diagnostics, medical devices, nutritionals, and branded generic medicines, serving people in more than 160 countries.