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 shipping 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. The Batch Record Reviewer works under the direct supervision of the QA Batch Record Review Supervisor and senior Quality Assurance management. This position may include travel between the Pharmaforce 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, as well as cGMP and health and safety requirements.
Submit error free batch records for product shipment.
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.
We all must embrace the QUALITY culture.
Qualifications and Requirements
High School Diploma or GED equivalent required. Associates or Bachelor's Degree preferred.
Two to three years equivalent experience with cGMP batch record documentation preferred.
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 Physical 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.
American Regent Inc. endeavors to make 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 .
We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
