Batch Records Team Leader - Altavista, VA Plant (1St Shift)

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.

Abbott's Nutrition Division 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, Glucerna and ZonePerfect - to help get the nutrients they need to live their healthiest life.

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.

WORKING AT ABBOTT

At Abbott, you can have a good job that can grow into a great career. We offer:

• Fast paced work environment where your safety is our priority

• 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 - 3 weeks 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 company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

• The stability of a company with a record of strong financial performance and history of being actively involved in local communities

Learn more about our benefits that add real value to your life to help you live fully: www.abbottbenefits.com

The Opportunity

This Batch Records Team Leader position works out of our Altavista, VA location in the Abbott Nutrition Division.

• This position could have some off shift requirements

What You'll Work On

• Provide support and assistance in coordination of day to day activities of batch auditing.

• Ensure that the batch records auditing process is compliant with policies, procedures and regulatory requirements before product is release for market distribution.

• Deemed a qualified person to release product to market.

• Audit all batch records to assure that the batch files comply with all policies, procedures and regulations affecting the product. This includes the Infant Formula Regulations, Food GMP'S, Kosher Law and Low Acid Food Regulations. Provide Batch Log trend information to management.

• Identify batch non-conformances or potential non-conformances and initiate appropriate actions.

• Review batch records for accuracy, completeness and compliance to all Abbott policies, procedures, deviation requirements and regulations.

• Follow up on all issues to assure each is dispositioned appropriately for batch release.

• Ensure work orders, Exception Reports, SQE's, discrepancies and Alert levels are documented to capture in metrics.

• Use enterprise inventory control systems to adjust, obtain and perform release status for specific batches.

• Provide support for data collection, i.e. Engineering and DQA

• Expedite batch review and release when asked by Division or Site Management to meet consumers' demands.

• Assist supervisor as business needs dictate. Back up for Batch Records auditors

• Document and occasionally lead Batch Auditor Staff Meetings.

• May provide administrative support to PQA manager and staff, including but not limited to:

• Data input and tracking and trending of QA data.

• Assist in the training to new employee's and develop training procedures and/or job aids. Provide training to internal and external personnel on procedures he/she is authorized to train on.

• Assist in internal and external audits as required.

• Perform other duties assigned by department management

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

Required Qualifications

• High School Diploma/GED.

• Relevant experience in Quality Assurance and/or Manufacturing.

• Proficient in computer applications.

Preferred Qualifications

• Certification of Low Acid Food processes

• Knowledge of applicable regulatory standards and requirements for infant formula and nutritionals.

• A good working knowledge of Low Acid Food Regulations, Infant Formula Regulations, Corporate Policies, Divisional Policies and Guidelines, Plant procedures and other governmental (local or federal) regulations affecting the manufacturing and distribution of the products produced in the plant.

• Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity and a Military/Veteran Friendly employer.

The base pay for this position is $29.35 - $58.75 per hour. In specific locations, the pay range may vary from the range posted.