QA Batch Record Supervisor

American Regent, Inc.•New Albany, OH

About The Position

The QA Batch Record Supervisor ensures quality in assigned areas by executing site policies, procedures, programs, and work instructions. The role ensures documentation, processes, products, and batch records meet specifications and applicable GMP requirements, supporting the manufacture of safe, pure, effective, and sterile pharmaceuticals in accordance with company SOPs. The supervisor provides direction and support to the Batch Record Review group, collaborates with other departments on production issues, product dispositions, and investigations into root causes, and is directly responsible for training and supporting performance assessments of QA Batch Record Reviewers I, II, and III. The role ensures reviewers comply with quality programs and manages departmental documentation workflow.

Requirements

High school diploma or GED required.
At least 5 years of experience in a regulated environment, such as QA, Compliance, Auditing, Laboratory, or Inspection, within a GMP environment.
At least 1 year of prior experience in a leadership role.
Strong leadership skills and ability to work within a team and assist in developing others.
Knowledge and demonstrated understanding of quality assurance principles, controls, and interactions between Quality Systems; FDA guidance; ICH; PIC/S; and related requirements.
High level of technical expertise, ownership, and practical knowledge of QA and regulatory programs.
Strong attention to detail, adherence to SOPs, and demonstrated practical application.
Ability to work effectively in a collaborative environment and manage multiple activities under dynamic constraints while producing strong results.
Strong organizational, interpersonal, and oral and written communication skills; written work must be audit-level appropriate for non-routine or complex issues.
Ability to read Standard English documents such as SOPs, maintenance schedules, and operating manuals.
Strong conflict-resolution skills and presentation skills suitable for management and cross-functional meetings.
Strong PC skills, including Microsoft Word and Excel.
Demonstrable analytical thinking and problem-solving skills.
Ability to occasionally lift and/or move up to 25 pounds.
Flexibility to wear cleanroom or protective gowning and equipment, including gowns, goggles, face shields, and protective gloves.

Nice To Haves

Bachelor’s degree in Science.

Responsibilities

Maintain quality objectives and conduct accurate verifications, including identifying batch record gaps, reporting and escalating issues, developing corrective actions and sampling plans, and performing accurate documentation assessments.
Supervise QA Batch Record Reviewers I, II, and III, including scheduling, training, coaching, mentoring, and supporting departmental work.
Partner with personnel to resolve errors and discrepancies according to SOP requirements and represent QA at cross-functional meetings.
Plan schedules to meet product-release deadlines and prevent gaps or downtime.
Work to ensure a positive customer experience.
Ensure work is performed and documented in accordance with company policies and procedures, cGMP, and health and safety requirements.
Apply working knowledge of cGMPs and supporting regulatory documents.
Partner with other departments to implement timely procedure changes based on predetermined specifications.
Update metric reports for trending.
Ensure errors and corrections are resolved according to SOP requirements.
Identify quality process improvements to increase quality and efficiency in systems, operations, and personnel.
Submit error-free batch records for product shipment.
Submit Change Requests as needed.
Support investigations and Corrective Actions/Preventative Actions (CAPAs), including report writing.
Mentor and guide less senior QA Batch Record Review Associates.
Perform other tasks and duties as assigned by management.