The Quality Assurance Manager (QA Manager) is a vital position in the operations of Celltex’s laboratory services. The primary responsibility of the QA Manager is to conduct and facilitate internal and external audits to assure compliance of products and processes to Celltex’s specifications and satisfaction. In addition, the QA Manager assures that products, processes, facilities, and systems conform to quality standards and relevant governmental regulations (FDA).
• Review and improve quality system documentation; write and/or review Quality Assurance (QA) standard operating procedures to assess cGMP compliance on issues relating to sterile biologics manufacturing
• Perform audits of manufacturing and quality control practices and procedures, including internal audits, vendor qualification audits, and audits of investigator sites
• Supervise the QA Specialist on audit-related work, during final production and quality control record review, and during the release of finished products
• Lead inspection and accreditation procedures as necessary, including leading and overseeing audit/ inspection preparation activities and remediation plans
• Conduct weekly quality review meetings and prepare reports
• Develop and conduct GXP and safety training courses for all staff annually, post-audits, and as necessary, and maintain staff GMP training records
• Develop budgets and monitor expenditures related to Quality Assurance activities and programs
• Manage recalls and returned products
• Manage the document control system, including document issuance and retirement, and maintenance of document history files
• Evaluate the adequacy and effectiveness of corrective and preventive action plans
• Prepare, organize, track and perform QA review of FDA submissions to include: INDs, Annual Reports, Supplements, etc.
• Provide interpretation of GMP/ GTP/ GCP regulatory requirements as they apply to Celltex
Strong interpersonal, leadership and communication skills; exceptional analytical and problem-solving skills with great attention to detail and precise organization and record-keeping practices. Must be familiar with GMP and FDA requirements, and possess knowledge of GMP documentation. Must be able to work flexible hours and before/after normal business hours on short notice.
Bachelor’s degree in relevant engineering or biological sciences and at least 8 years of experience in Quality Assurance, with at least two years in management or a supervisory Quality Assurance position.
For more information, please contact Diane Dolence at firstname.lastname@example.org