QA Batch Record Review II

American Regent, Inc.•New Albany, OH

About The Position

The QA Batch Record Reviewer II is a member of the Quality Assurance (QA) Batch Record Review Group and provides QA review associated with manufacturing safe, pure, effective, and sterile pharmaceuticals in accordance with company SOPs, policies, and current Good Manufacturing Practices (cGMPs). The group supports other departments as needed and helps maintain product release schedules and meet company goals. The role reviews and corrects batch record documentation, collaborates with multiple departments on metrics and exception reporting, and applies knowledge of regulatory documents and cGMPs. It includes travel between American Regent facilities. The reviewer also supports investigations and CAPAs, provides guidance to plant personnel and less senior reviewers, and may perform other tasks assigned by management.

Requirements

High school diploma or GED equivalent.
A minimum of two years of equivalent experience with cGMP batch record documentation.
QA, Compliance, and Auditing experience in a cGMP manufacturing environment.
Strong attention to detail and adherence to SOPs.
Intermediate skills in Microsoft Word and Excel.
Excellent organizational, interpersonal, and written and oral communication skills.
Demonstrable analytical thinking and problem-solving skills.
Ability to manage multiple activities at the same time while producing outstanding results.
Ability to take feedback constructively and function in a team-oriented work environment.

Nice To Haves

Associate or bachelor's degree.
Ability to meet and maintain clean gowning requirements.

Responsibilities

Perform critical review of executed batch record documentation.
Enter data into applicable spreadsheets and databases.
Update metric reports for trending.
Work with personnel to ensure errors and corrections are resolved according to SOP requirements.
Identify quality process improvements to increase quality and efficiency in systems, operations, and personnel.
Ensure work is performed and documented in accordance with company policies and procedures, the Code of Federal Regulations, mutually recognized agreements with international regulatory bodies, and health and safety requirements.
Submit error-free batch records for product release.
Submit Change Requests as needed.
Support investigations and Corrective Actions/Preventative Actions (CAPAs), including report writing.
Mentor and provide guidance to less senior QA Batch Record Review Associates.
Provide guidance for plant personnel on batch record corrections.
Perform other tasks and duties assigned by management.