Batch Records Reviewer Team Leader

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 115,000 colleagues serve people in more than 160 countries.

     

JOB DESCRIPTION:

ABOUT ABBOTT

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.

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 + 5 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.

PRIMARY FUNCTIONS

• Assure compliance to Federal Regulations pertaining to Low Acid Canned Foods, Infant Formula Quality Control, Acidified Foods, Bottled Water Regulations, Nutritional Labeling Laws, and Good Manufacturing Practices.
• Audit and assure accuracy of all batch records to be compliant with policies, procedures and regulatory requirements.
• Provide guidance and resources for Batch Auditor's related to batch auditing, assuring that all necessary documents are retained in the batch record.
• Coordinate batch auditing assignments and assists with QS Projects, reworks, holds, destructs, etc.
• Coordinate training requirements for Quality Systems.
• Maintain various QS Databases and daily communicate batch status
• Identifies batch non-conformances and initiate appropriate actions for those non-conformances.
• Writes job aids/reviews procedures, maintaining their accuracy.
• Play a lead role in resolving issues.
• Provide back up to the Quality Systems Supervisor/Batch Records Supervisor, when necessary.
• Deemed a qualified person to release product to commerce.
• May be called upon to support and facilitate audits and regulatory inspections.
• Verify quality assurance regulations are met in documentation, i.e. work orders, checklists, charts, EBR, etc.

MAIN RESPONSIBILITIES

Responsible for implementing and maintaining the effectiveness of the quality system.

• Assign batch records to auditors and direct/guide the daily workflow based upon batch release priorities.
• Batch audit: Review work orders for completeness and compliance to all Abbott policies, procedures, /Deviation requirements and Government regulations.
• Write correction plans for ER's, sampling plans and effectiveness checks; document ER implementations; 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.
• Back up Batch Records Coordinators/auditors with t