- Serves as the quality subject matter expert related to all quality matters involving manufacturing,packaging, warehousing and supporting operations
- Reviews and approves Good Manufacturing Practices (GMP) Master documents and oversees release of manufactured batches
- Responsible for the Internal Audit and Supplier Audit Programs
- Reviews and approves change controls, deviations, CAPAs, non-conformances, and customer complaint investigations in MasterControl
- Communicates any Quality matters with customers as agreed upon in Quality Agreements
- Facilitates and hosts customer audits to support review of manufacturing and quality systems
- Participates/supports Regulatory audits of the facility by the FDA and other health authorities
- Assist in the coordination and approval of annual product reviews; and sharing of approved reports with business customers (as required per contract)
- Conducts routine introductory training of new hires on the basic GMP requirements needed for the Pharmaceutical industry
- Works with QA Director on continuous improvement projects for existing processes and Quality Systems
- Bachelor's Degree from an accredited college or university and at least five (5) years of related experience and/or training; or equivalent combination of education and experience.
- Possess understanding of U.S. cGMPs, applicable GMPs from other regulatory bodies which produces pharmaceutical products, and Quality Systems.
- Ability to maintain objectivity and perform root cause analysis.
- Possess excellent interpersonal and communication skills.
- Must have advanced computer software skills in Microsoft Office Suite.
- Knowledge of Master Control Quality Management and the Ross ERP system is preferred.
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Quality Assurance Manager - Boerne, United States - Military Technical Recruiting (MTR)
Description
Job Description
Job DescriptionThe Quality Assurance (QA) Manager has overall responsibility for all internal quality assurance functions, which includes batch release and the execution of the following quality systems including: Complaints, Events(Deviations and non-conformances), (Corrective Actions/Preventive Actions (CAPAs), Effectiveness Checks,Annual Product Reviews and other quality related tasks. The Quality Assurance Manager leads the QA team in accordance with policies and applicable state and federal laws including but not limited to:interviewing, hiring and training employees; planning, assigning and directing work; appraising performance and developing team members coaching and counseling when appropriate; ensures a harmonious and efficient team operation by addressing concerns and resolving team issue.Requirements
BenefitsFull Comprehensive Benefits
1st day of next month after hire
401K
United Health Care
