Quality Assurance Specialist for Contract Manufacturing
4 weeks ago
This role is part of the Quality Assurance team at American Regent, Inc. The QA Contract Manufacturing Organization Specialist is responsible for ensuring the quality of pharmaceutical products manufactured by third-party contractors. The Specialist will review batch records, ensure compliance with cGMPs and company SOPs, and collaborate with other departments to maintain shipping schedules and third-party relationships.
Key Responsibilities
- 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.
Requirements
- 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.
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New Albany, Ohio, United States American Regent, Inc. Full timeJob Summary:The QA Contract Manufacturing Organization Specialist is a critical member of the Quality Assurance team at American Regent, Inc. This role is responsible for ensuring the quality of pharmaceutical products manufactured by third-party contract manufacturers.Key Responsibilities:Provide quality assurance review of batch records to ensure...
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