QA Batch Record Review II

Nature and Scope

This position is member of the Quality Assurance (QA) Batch Record Review Group. The QA Batch Record Reviewer II 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

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time.

• 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.
• Demonstrated basic knowledge of cGMPs and supporting regulatory documents.
• 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.

Education Requirements and Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.

• 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.
• 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.

American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.

Applicants have rights under Federal Employment Laws.

• FMLA poster: https://www.dol.gov/whd/regs/compliance/posters/fmlaen.pdf

• Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov)

• Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf

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