Job Summary:This position will be responsible for the site wide quality management program designed to ensure continuous measurement and improvement in site performance. This includes implementing global initiates, at the site level, to ensure the reproducibility of operations in line with global programs. The position will employ effective tools to support risk mitigation of quality breaks and to respond to quality breaks implementing measures to correct and prevent future occurrences. The position will also be responsible for ensuring compliance to applicable laws, guidelines and regulation governing the sites operations. The success of the role will be measured by improvements in site quality and efficiency of operation, meeting or exceeding client expectation and corporate goals and objectives.
Responsibilities:- Provide focus for the Quality Management System and work closely with all departments and functions to promote processes that ensure consistency, continuous improvement and compliance with quality and business requirements
- Provide support for Quality Systems and maintain the appropriate level of customer service.
- Prepare, host, and respond to findings for external audits (e.g.: regulatory, ISO/CAP/CLIA, client, etc.)
- Prepare non conformance reports and monitoring reporting performance and trends
- Problem solve, identification of root cause and implementation/follow up of corrective procedures and preventive actions to ensure timely resolution of such problems
- Ability to perform internal audits as required according to site and global plans
- Use auditing as a proactive tool for improvement as well as compliance and challenge existing practice where appropriate
- Timely completion and follow up through to closure of CAPA actions
- Measuring and monitoring of performance against agreed KPIs
- Collate and share information/data across the site as appropriate through reports and follows up on identified improvement opportunities
- Actively contribute to the success of the overall QA team and the site
- Responsible for ensuring the company and its quality management system (QMS) meets relevant regulations and standards (e.g., FDA, QSR, ISO standards, CLIA, CAP, GLP, GDP, EH&S) and other guidelines.
- Oversee supplier/vendor management, assuring that vendors are operating in compliance with the applicable quality program and regulations guidelines.
- Managed QA department and quality activities such as document control, training, calibration, complaints, incoming inspection, nonconformance, deviation, CAPA system, supplier management system, internal and external audits.
- Support site EHS program
- Actively participate and/or drives EU/Global QMS improvements as required
Minimum Requirements:- Requires a Bachelor's degree in a scientific discipline
- Requires minimally 5 years of related quality assurance experience
- Experience with CAP/CLIA is required
- Able to make competent decisions based on a review of analytical data
- Able to write clear, coherent internal business communications / reports and presents results of work
- Willing and able to work under the pressure of deadlines and find solutions to meet timelines.
- Ability to work across teams by being a flexible team player with strong communication and interpersonal skills.
- Comfortable using computers, including a working knowledge of Microsoft Office programs, e-mail, and internet.
- Exceptional organizational and time-management skills. Ability to multi-task with a high degree of professionalism and diplomacy.
Preferred Requirements:- Experience in the life sciences industry is preferred
- Experience with ISO 9001 is preferred
- Ability to work in an in-vivo laboratory environment is preferred
- Experience in GLP/GCP regulated environment is preferred
- Experience with EHS programs is preferred
Salary range is $120,000-140,000
This salary (or salary range) is merely an estimate and may vary based on an applicant's skills and prior relevant experience.
