QA Batch Record Reviewer II – cGMP & CAPA

American Regent; New Albany (OH); Presencial; USD 75 000 - 90 000; Tempo integral

Resumo da oferta

American Regent is seeking a QA Batch Record Reviewer II to perform critical review of executed batch records for sterile pharmaceuticals, ensuring compliance with cGMPs, SOPs and regulatory expectations. You will collaborate across departments to resolve issues, update metrics, and support product release schedules.

This role requires attention to detail, data integrity, and strong documentation and communication skills; travel between American Regent facilities is expected.

Qualificações

• High School Diploma or GED equivalent required.
• Associate or bachelor’s Degree preferred.
• A minimum of two years equivalent experience with cGMP batch record documentation is required.
• QA, Compliance and Auditing experience in a cGMP manufacturing environment is required.
• Strong attention to detail and adherence to SOPs.
• Intermediate skills in Microsoft Word and Excel are required.
• Excellent organizational, interpersonal and communication skills (written and oral) required.
• Demonstrable analytical thinking and problem-solving skills.
• Demonstrated success in managing multiple activities at the same time, producing outstanding results.
• Ability to meet and maintain clean gowning requirements is preferred.

Responsabilidades

• Perform critical review of executed batch record documentation.
• Enter data into applicable spreadsheets/databases.
• Update metric reports for trending.
• Work with personnel to assure that all errors and corrections are resolved according to SOP requirements.
• Identify quality process improvements to increase quality and efficiencies in systems, operations, and personnel.
• 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 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.
• Mentors and provides guidance for less senior QA Batch Record Review Associates.
• Provides guidance for plant personnel on batch record corrections.
• Perform any other tasks/duties as assigned by management.

Conhecimentos

Attention to detail

Analytical thinking

Problem-solving

Communication skills

Teamwork

Formação académica

High School Diploma or GED

Associate degree

Bachelor’s degree

Ferramentas

Microsoft Word

Microsoft Excel

Descrição da oferta de emprego

American Regent is seeking a QA Batch Record Reviewer II to perform critical review of executed batch records for sterile pharmaceuticals, ensuring compliance with cGMPs, SOPs and regulatory expectations. You will collaborate across departments to resolve issues, update metrics, and support product release schedules.

This role requires attention to detail, data integrity, and strong documentation and communication skills; travel between American Regent facilities is expected.