Quality Assurance Manager at PPC Limited

Reporting to: The Center Manager
Job Type: Permanent

Summary of Role / Responsibilities

• Plans, directs and coordinates the efforts of Quality Assurance (QA) team towards maintaining an effective quality system
• Manages, maintains and improves the QA system to meet the regulatory standards needed by business areas.
• Oversees the review, update and maintenance of all SOP’s and other QA documents
• Responsible for the accreditation portfolio and working with managers to ensure all requirements are met in a timely manner.
• Performs regular clinical audit to ensure compliance to our quality system and governing regulatory body requirements
• Executes and upholds all clinical and state license
• Communicate any critical compliance risks, surveys, analysis and recommendations to senior management
• Ensures regulatory rules are communicated through corporate policies and procedures
• Assumes a lead role for the preparation, conduct, and responses to regulatory agency
• Responsible for the coordination of all laboratory activities to ensure compliance with the laboratory and corporate Quality Systems
• Assists in the development, notification and implementation of Quality Control Systems
• Assists in the development of training and competency of all clinical employees in the areas of processes, health & Safety, etc.
• Monitors compliance with standards established by regulatory and accrediting bodies such as MLSCN, Clinical Laboratory Improvement Amendments
• Establishes, Maintains and Manages an instrumentation inventory to ensure all CLIA standards are met
• Assists with the preparation, coordination, and management of regulatory agency inspections
• Conduct quarterly internal reviews of all direct service areas and preparing quantitative and qualitative outcomes based reports.

Qualification and Experience

• B.Sc. preferably in a Scientific discipline or Life Sciences; Master's Degree will be an added advantage
• At least 5 years of relevant experience in a CLIA or CAP regulated environment preferred
• Knowledge of a high complexity clinical testing environment
• Must possess the technical and administrative abilities required to carry out routine audits with minimal supervision and to play a supporting role in more complex audits
• Must possess excellent communication and writing skills, patience, professionalism and ability to effectively interact with staff and management alike
• Ability to verbally communicate effectively with team members and multiple departments.