QA Batch Record Lead

Nature and Scope
This position 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 Procedures. The Batch Record Reviewer Lead ensures all documentation, processes and products meet specifications and that Batch Records are completed in accordance with GMP requirements prior to lot disposition. This position requires effective collaboration with other departments on production issues/situations, product dispositions and investigations into root cause for deficiencies. The Batch Record Reviewer Lead works under the direct supervision of the QA Supervisor.
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.

• Maintain quality objectives and conduct accurate verifications, including but not limited to, identifying Batch Record gaps, reporting, and escalating issues.
• Effectively resolve documentation errors and discrepancies with manufacturing operations personnel according to SOP requirements and GMP standards.
• Reviews all batch documentation for accuracy and completeness according to cGMP's to ensure timely release of batches.
• Ensure all work is performed and documented in accordance with existing Company policies and procedures, as well as cGMP, health, and safety requirements.
• Execute Batch Record review and review of supporting systems, to include Trackwise and Veeva Vault.
• Execute final batch disposition based on review of all associated documentation.
• Execute Batch Record review of Media Fills and Research and Development (R&D) batches.
• Adheres to internal and external guidelines, specifications and regulatory requirements while reviewing batch documentation.
• Working knowledge of cGMPs and supporting regulatory documents and apply appropriately.
• Update metric reports for trending as needed.
• Work with personnel to assure that all errors and corrections are resolved according to SOP requirements.
• Assist in the overview of the Certification of Disposition process.
• Mentors and provides guidance for less senior QA Batch Record Reviewers.
• Review and approve preliminary Batch Records after Batch Record assembly.
• Review logbooks for accuracy after creation.
• At any time may be required to perform the job responsibilities for the Documentation Specialist.
• 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 required. Associate or bachelor's degree in science preferred.
• Minimum of five (5) years of experience in a regulated environment preferred.
• 1-year prior experience in a leadership role preferred.
• Knowledge and demonstrated understanding of quality assurance principles, controls, and interactions between Quality Systems; FDA guidance, ICH, PIC/S, etc.
• A high level of technical expertise, ownership, and practical knowledge of QA/regulatory programs.
• Strong attention to detail, adherence to SOPs, and demonstrated practical application.
• Demonstrated ability to work effectively in a collaborative environment.
• Demonstrated ability to effectively work under dynamic constraints, with success in managing multiple activities concurrently and producing outstanding results.
• Must be able to read documents in Standard English such as Standard Operating Procedures, maintenance schedules and operating manuals.
• Strong organizational, interpersonal and communication skills (oral and written). Written skills must be audit-level appropriate for non-routine or complex issues.
• Strong conflict resolution skills.
• Good presentation skills, suitable for management and cross-functional meetings.
• Strong PC Skills Required (MS Word, Excel).
• Demonstrable analytical thinking and problem-solving skills.
• Ability to work overtime as needed.

Physical Environment and Requirements

• Employee must be able to occasionally lift and/or move up to 25lbs.

Expected Hourly Rate:
$32.94-$36.06
The hourly rate displayed is the minimum and maximum hourly rate of compensation for the role that the employer in good faith believes to be accurate at the time of the posting of an advertisement for the role. Actual compensation for the role will be based on a number of different factors including but not limited to the candidate's qualifications, education, knowledge, skills and experience.
American Regent also offers a competitive total rewards package which includes healthcare, life insurance, profit sharing, paid time off, matching 401k as well as a wide
range of other benefits.
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 https://americanregent.com/Careers 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 hrtalentacquisition@americanregent.com.