QA Batch Record Supervisor

Nature and Scope

This position is responsible for ensuring the overall quality in their assigned areas through the execution of site policies and procedures, programs, and work instructions. Ensures all documentation, processes and products meet specifications and that Batch Records are completed in accordance with GMP requirements. The QA Batch Record Supervisor is responsible to provide direction and support to the Batch Record Review group as associated with the manufacture of safe, pure, effective, and sterile pharmaceuticals in accordance with company Standard Operating Procedures (SOP’s). This position requires effective collaboration with other departments on production issues/situations, product dispositions and investigations into root causes for deficiencies. The Batch Record Review Supervisor is directly responsible for training, and support performance assessment of QA Batch Record Reviewers (I, II, and III). The Supervisor ensures QA Batch Record Reviewers maintain compliance with quality programs.  The Supervisor is responsible for managing the workflow of documentation withing the department.

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, developing corrective actions, sampling plans, accurate documentation assessments.

·       Supervise QA Batch Record Reviewers (I, II, III) on department support, including scheduling, training, coaching and mentoring.

·       Partner with personnel to resolve errors and/or discrepancies according to SOP requirements.  Represent QA at cross-functional meetings.

·       Plan schedules to meet deadlines for product release and prevent gaps or downtime

·       Work to ensure a positive experience for customers

·       Ensure all work is performed and documented in accordance with existing Company policies and procedures, as well as cGMP, health and safety requirements.

·       Working knowledge of cGMPs and supporting regulatory documents and apply appropriately.

·       Partner with other departments to implement timely procedure changes, based on predetermined specifications.

·       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.

·       Submit error free batch records for product shipment.

·       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.

·       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. Bachelor’s degree in Science, preferred.

·       Minimum of 5+ years of experience in a regulated environment (QA, Compliance, Auditing, Laboratory or Inspection, within a GMP environment), required.

·       Minimum 1 year prior experience in a leadership role, required.

·       Must have strong leadership skills and be able to work within a team and assist in developing others.

·       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.

·       Strong organizational, interpersonal and communication skills (oral and written). Written skills must be audit-level appropriate for non-routine or complex issues.

·       Must be able to read documents in Standard English such as Standard Operating Procedures, maintenance schedules and operating manuals.

·       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.

Physical Environment and Requirements

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

·       Employee must be flexible to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, and protective gloves.

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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