BioPhase Solutions specializes in recruiting top talented professionals for San Diego's Scientific community. We are currently looking for a QA Manager to work for a leading San Diego biotechnology company.
Responsible for providing Quality support to all functions with focus on compliance in accordance with, regulations and standards set forth by regulatory and accrediting agencies for diagnostic divisions of the company. This position provides direct support in supplier qualifications and supplier management, design control, manufacturing and laboratory areas in assuring that Quality System Records and the Quality Management Systems are in compliance with regulatory standards and promote continuous improvement of the Quality System.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Provides quality oversight in product development and design control activities (consistent with FDA Medical Device Quality Systems Regulation) to ensure that product features meet quality, reliability, manufacturability, and cost requirements.
Participates in the development, implementation, and maintenance of the company's Quality Management System.
Provides oversight and leadership for the Quality Systems external and internal audit program, training/qualifying audit teams, providing guidance/direction, facilitating/conducting audits and assisting in closure of corrective actions assigned in response to identified observations/findings.
Provides oversight in development, review and approval of documents to ensure compliance with established procedures and regulations (e.g., change management, master and executed batch record review and release, deviations, specifications, reports, CAPA and SOPs).
Participate in the deviation, CAPA and training programs for cGMP compliance, assisting in root cause investigations (deviations, customer complaints, CAPA, etc.) ensuring compliance to procedures/regulations.
Provides support to quality management in the preparation for, conduct of, and follow-up activities associated with site visits from clients and regulatory/accrediting agencies
Provides quality oversight in preparation for and in conduct of inspections/audits by regulatory agencies (FDA, CAP, and NYSDOH) and customers
BioPhase Solutions - 22 months ago
copy to clipboard