Job Title: Quality Assurance Manager
Location: Irvine, CA 92618
Duration: 06 Months+
The position provides QA review and approval of new and existing methods/procedures, validation/transfer protocols, investigations, corrective/preventive action plans and change control documents. This position also participates as an SME in external and internal audits of operational areas, provides support, direction and representation for quality management as a decision maker.
Essential Areas Of Responsibility
All areas of responsibility listed below are essential to the satisfactory performance of this position by any incumbents with reasonable accommodation if necessary. Any non-essential functions are assumed to be included in other related duties or assignments.
• Responsible for maintaining work areas and performing job functions in a safe and efficient manner in accordance with company policies and procedures, Good Manufacturing Practices (cGMP’s), Standard Operating Procedures (SOP’s) and Batch Record instructions.
• Responsible for completing all training requirements and maintaining 100% compliance with all assignments.
• Responsible for the daily management and development of direct reports.
• Responsible for providing a thorough, timely review and approval of cGMP documents and processes such as those related to validation, change control documentation, deviations, investigations, qualification, protocols and reports, facility controls, instruments and procedures.
• Responsible for providing QA support and/or review and approval of Annual Product Reviews, Continuous Process Verification and Risk Assessments
• Responsible for acting as an SME and participating directly in internal/external audits.
• Responsible for actively supporting and managing partner relationships.
• Responsible for supporting the development and execution of validation protocols for equipment, processes, products, and affected facility or utility areas.
• Responsible for working with operating departments to facilitate process improvements and lean concepts.
• Responsible for performing additional related duties as assigned.
Any equivalent combination of education, training and/or experience that fulfills the requirements of the position will be considered.
• Requires a Bachelor’s Degree in Science or Engineering from an accredited college or university with a minimum of 10 years relevant progressive QA experience in the pharmaceutical or a related industry.
• Requires experience with and an in-depth knowledge of cGMP and other applicable industry regulatory requirements as they relate to the production of pharmaceutical products and associated quality systems.
• Experience with an in-depth knowledge in sterile operation and Aseptic filling of at least 5 years
• Requires experience with the handling of deviations, investigations and CAPAs.
• Requires experience with managing partner relationships.
• Experience with Manufacturing/Quality systems such as Trackwise, LIMS/Labware, ERP and EDMS Systems and statistical software preferred.
• Experience with laboratory related investigations/inquiries preferred.
• ASQ/CQE/CQA Certification preferred.
• Detail oriented with ability to analyze information and create corresponding performance metrics.
• Computer proficiency with comprehensive working knowledge of MS Office products and computer relational databases.
• Ability to demonstrate sound judgment and decision making.
• Ability to build and maintain collaborative relationships between teams, departments and business units.
• Motivate, influence and lead others with and/or without direct supervisory authority.
• Communicate effectively with excellent written and oral communication skills.
• Interact positively and collaborate with co-workers, management and external partners.
• Manage conflict and negotiate resolution.
• Self-directed with ability to organize and prioritize work.
- • Project management and advanced presentation skills preferred.
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