Batch Records Team Leader- Columbus 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 115,000 colleagues serve people in more than 160 countries.

Main Purpose of Role:

Individual contributor that works under limited supervision.

Applies subject matter knowledge.

Requires capacity to understand specific needs or requirements to apply skills/knowledge.

Primary Function I Primary Goals I Objectives:

• 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.

Major 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 CAM BAR and Amaps to adjust/obtain/perform release status for specific batches.
• Back up Batch Records Coordinators/auditors with the following tasks:
• Ensure holds and isolations have been initiated and address as required and verify all sort/destruct issues are ccompleted and documented in workorder.
• · - Responsible for the generation of weekly, quarterly and annual reports and data retrieval
• - First audit review, if needed
• - Non-auditing tasks (CIP chart reviews, tank chart reviews, etc).
• H. Initiate work order change requests if the need arises.
• I. Assists with training new employees where needed.
• J. Provide support for data collection, i.e.: PQA lab, Engineering and DQA
• K. Expedite batch review when asked by Division to meet consumers demands.
• L. Assist supervisor as business needs dictate.
• M. Document and occasionally lead Batch Auditor Meetings
• N. 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

Background:

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

Some knowledge of the manufacturing process including Analytical Processing and Filling preferred.

Proficient in computer applications.

Ability to analyze and trouble shoot.

Must have strong communication and writing skills.

Ability to prioritize workload to meet deadlines.

Certification of Low Acid Food processes

The job description is illustrative of the types of duties typically performed by this job. It is not intended to be an exhaustive listing of each and every essential function of the job. Since job content may change from time to time, the Company reserves the right to modify this job description at any time.

Education:

Bachelor’s Degree preferred, or 3-5 years of demonstrated excellence of on the job experience in a QS or leadership role.

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, PR&D groups, AR&S groups and Process Authority on technical subjects effecting product quality and plant operations. The incumbent should have some technical knowledge in the areas of processing, filling, aseptics, chemistry, microbiology, computers as well as excellent oral and written communication skills.

Accountability / Scope / Budget:

The position will report directly to the Quality Systems Supervisor I Batch Records Supervisor and will coordinate the activities and work function of the batch auditors. The position will directly impact the performance of the plant, meeting the production schedule, releasing product and new product launches. This position may be independent but in many instances will provide direction and guidance as well as be a resource to others within the department.