The Senior QA Specialist will provide oversight for the startup and ongoing manufacturing operations at a new biopharmaceutical manufacturing facility, focusing on timely resolution of departures from established standards and ensuring compliance with GxP requirements.
Requirements
- Experience providing quality oversight or supporting compliance activities for a commercial GMP facility.
- Experience with single use equipment and an understanding of upstream, downstream and/or manufacturing support biotechnology principles is desired.
- Must thoroughly grasp and be able to clearly present technical concepts.
- Possess technical writing and problem-solving skills
- Understanding of FDA, EU and ROW cGMP regulations is required.
- Ability to read, analyze, and interpret, general business periodicals, professional journals, technical procedures, or governmental regulations.
- Ability to write reports, business correspondence, and procedure manuals.
Responsibilities
- Works directly with Manufacturing, QA and other departments responsible for GMP activities to resolve production related deviations and other compliance issues in a timely manner.
- Review and approve Deviations and CAPAs.
- Ensure completion of Root Cause Analysis, CAPAs and Effectiveness Checks for Deviations according to cGMP requirements.
- Objectively verify technical accuracy and facts associated with departures from standards contained within Deviation report
- Supports the generation of metrics, trends, and project specific status updates of Deviations and CAPAs.
- Collaborates with functional areas to improve the Deviation/CAPA system, to include support in development of training materials and training personnel.
- Support client audits and regulatory inspections as required
Other
- Willingness to learn by interacting with peers, Operations staff, and individually through document review is required.
- Demonstrated strong interpersonal skills, ability to work in a team environment, attention to details and excellent problem resolutions skills.
- Ability to effectively present information and respond to questions from groups of managers, clients, customers, and auditors.
- Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
- Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
