Batch Records Auditor - 1st Shift - Altavista, VA Plant

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.

     

JOB DESCRIPTION:

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to:

• Production areas that are clean, well-lit and temperature-controlled
• Training and career development, with onboarding programs for new employees and tuition assistance
• Financial security through competitive compensation, incentives and retirement plans
• Health care and well-being programs including medical, dental, vision, wellness and occupational health programs, Medical Benefits start day 1
• Vacation – 120 hours of accrued vacation (1st yr is prorated) + vacation buy program + 3 personal days + 10 paid holidays
• Retiree Healthcare program
• Robust 401(k) retirement savings with a generous company match
• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
• A stable company with a record of strong financial performance and history of being actively involved in local communities
• A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position works out of our Altavista, VA location in the Abbott Nutrition division. Our Nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow to keeping adult bodies strong and active. Millions of people around the world count on our leading brands – including Similac®, PediaSure®, Pedialyte®, Ensure®, and Glucerna® – to help them get the nutrients they need to live their healthiest lives.

Altavista, Va., is one of Abbott’s largest nutrition manufacturing plants equipped with advanced technology to ensure efficient production. Working here will make you feel like you’re part of a family that works together to make a difference and help nourish millions of families around the world.

What You’ll Work On

• Batch audit: Review work orders for completeness and compliance to all Abbott policies, procedures, /Deviation requirements and Government regulations.
• Disposition SQE’s and PIR’s for batch release.
• Follow up on all issues to assure each is dispositioned appropriately for batch release.
• Ensure work orders, ER’s, SQE’s, Discrepancies and Alert levels are documented for capture in metrics.
• Use CAMBAR and Amaps to adjust/obtain/perform release status for specific batches.
• Generate weekly, quarterly and annual reports and data retrieval, first audit review, and Non-auditing tasks (CIP chart reviews, tank chart reviews, etc.).
• Initiate work order change requests if the need arises.
• Assist with training new employees where needed.
• Provide support for data collection, i.e.: PQA lab, Engineering and DQA.
• Expedite batch review when asked by Division to meet consumers’ demands.
• Assist supervisor as business needs dictate.
• Document and occasionally lead Batch Auditor Meetings.
• On occasion, may provide administrative support to PQA manager and staff, including but not limited to: Data input and tracking and trending QA data, stats, test results, product pathway protection listing. Develop presentations for QA staff.

You’ll be accountable for meeting our compliance standards including FDA, OSHA and Abbott policies and procedures.

Required Qualifications

• High School Diploma/GED or equivalent experience.
• The incumbent must show strengths in Abbott core competencies and effectively communicate with all plant manufacturing groups, plant Quality Assurance groups, plant management, Division Quality Assurance, Logistics, Material Control,