QA Contract Manufacturing Organization Specialist

Nature and Scope

This position is member of the Quality Assurance (QA) External Manufacturing and Batch Record Review Group. The QA Contract Manufacturing Organization (CMO) Specialist 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) for product that is either manufactured for third-party or product manufactured from a third-party. The Specialist provides support to other departments and is critical in maintaining shipping schedules and meeting the needs of third-party relationships. Activities include change management, quality review of batch records, correction and approval of batch records, batch dispositions, complaints and investigations. The position requires collaborating with multiple departments regarding metrics, exception reporting and knowledge of regulatory documents and cGMPs. The CMO Specialist works under the direct supervision of the QA Manager, External Manufacturing.

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.
• Ensure all work is performed and documented in accordance with existing Company policies and procedures, as well as current Good Manufacturing Practices (cGMP) and health and safety requirements.
• Work with personnel to ensure that all errors and corrections are resolved according to SOP requirements.
• Provides guidance for plant personnel on batch record corrections.
• Supports the reviewing and approving of quality records/documentation from third parties, including but not limited to product and process change controls.
• Able to evaluate non-routine data and communicate conclusions.
• Update metric reports for trending.
• Identify quality process improvements to increase quality and efficiencies in systems, operations and personnel.
• Identify, develop and revise necessary company policies and procedures to support management of third-party partners and external service providers
• Facilitate approval and release of commercial product based on conformance to specifications, current Good Manufacturing Practices (cGMP's) requirements and/or contractual agreements (Quality Agreements)
• Supports positive relationships with CMOs
• Submit Change Requests as needed.
• Support investigations and Corrective Actions/Preventative Actions (CAPAs), including report writing.
• Assists resolving quality issues in conjunction with the senior QA staff including deviations, memos, investigations and CAPAs. Able to generate final reports with minimal supervision.
• 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 three years equivalent experience with cGMP batch record documentation is required.
• Must have QA Compliance and Auditing experience working in a cGMP manufacturing environment.
• Strong attention to detail and adherence to SOPs.
• Intermediate skills in Microsoft Word and Excel are required.
• Ability to develop metrics and perform trend analysis.
• Ability to digest and grasp manufacturing processes abstractly and remotely
• Working knowledge of current Good Manufacturing Practices, FDA and ICH Q8/9/10/12 guidelines
• 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 take feedback constructively and function in a team-oriented work environment.
• Demonstrated experience with use of electronic Quality Systems (Trackwise, VeevaVault, LIMS etc.)

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.

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