QA Batch Record Review I

Nature and Scope

This position is a member of the Quality Assurance (QA) Batch Record Review Group. The QA Batch Record Reviewer I is responsible for providing the Quality Assurance review associated with the manufacture of safe, pure, effective, and sterile pharmaceuticals in accordance with company Standard Operating Procedures (SOPs), policies and current Good Manufacturing Practices (cGMPs). The Batch Record Review group provides support to other departments as needed and is critical in maintaining product release schedules and meeting company goals. The quality review of the batch record includes the correction and approval of batch record documentation. The position requires collaborating with multiple departments regarding metrics, exception reporting and knowledge of regulatory documents and cGMPs. This position includes travel between the American Regent facilities.

Essential Duties and Responsibilities

• Performs a critical review of the executed batch record documentation.
• Work with personnel to resolve errors and/or discrepancies.
• Assures all errors and corrections are resolved according to SOP requirements.
• Enter data into applicable spreadsheets/databases.
• Update metric reports for trending.
• Ensure all work is performed and documented in accordance with existing Company policies and procedures, in accordance with Code of Federal Regulations, and mutually recognized agreements with international regulatory bodies as well as health and safety requirements.
• Submit error free batch records for product release.
• Oversee creation, assignment and closure of logbooks as requested by site-wide personnel. (Shirley only)
• Assign and maintain Lot Number Assignment for product lots to support weekly production filling activities. (Shirley only)
• Assemble, issue and check batch records for manufacturing process. (Shirley only)
• Perform any other tasks/duties as assigned by management.

Education Requirements and Qualifications

• High School Diploma or GED equivalent required. Associate degree preferred.
• Minimum one year of prior work experience and/or transferable skills is required.
• High attention to detail, basic problem-solving abilities, and clear written communication.
• Basic understanding of cGMP regulations, Good Documentation Practices (GDP), and pharmaceutical manufacturing workflows.
• Skills in Microsoft Word and Excel and Electronic Management Systems are required.
• Ability to take feedback constructively and function in a team-oriented work environment.
• Ability to work overtime as needed.

Physical Environment and Requirements

Employee must be able to occasionally lift and/or move up to 25 pounds.