QA Batch Record Review II

American Regent; New Albany (OH); On-site; USD 75,000 - 90,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Attention to detail

Analytical thinking

Problem-solving

Communication skills

Teamwork

Education

High School Diploma or GED

Associate degree

Bachelor’s degree

Tools

Microsoft Word

Microsoft Excel

Job description

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 ResponsibilitiesNothing 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 QualificationsTo 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 RequirementsEmployee 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.pdfKnow Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov)Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdfAlert: We’re aware of individuals impersonating our staff to target job seekers. Please note:· All legitimate communication will come directly from a verified ARI recruiter either by phone or via an americanregent.com email address.· Our recruiting process includes multiple in person and/or video interviews and assessments.· If you are unsure about the legitimacy of a message, contact John Rossini at [e-mail] before responding.· We never request payment, bank information, or personal financial details during our offer process.Your security is important to us, and we encourage you to stay vigilant when job searching.American Regent Inc. endeavors to make https://careers.americanregent.com/ accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email [e-mail].