Almac Group is a group of established businesses at the forefront of the Pharmaceutical industry. Our Company is a recognized global knowledge-based leader for the research, development, and delivery of pharmaceutical services. Almac Group's services extend from drug discovery through all areas of clinical trials to the commercialization of pharmaceutical products. Our commitment to Discovery, Development and Delivery in conjunction with our long term partnerships with the majority of the world's leading pharmaceuticals guarantees a secure future for everyone.
We are currently looking for a Quality Assurance Validation Specialist for our Durham, NC facility. The Quality Assurance Validation Specialist is responsible for supporting the daily, efficient running of the equipment and computerized systems in Almac Diagnostics Laboratories. This includes ensuring the correct and timely validation, commissioning, maintenance and calibration of clinical laboratory equipment and systems.
Responsibilities include but are not limited to:
Be responsible for compiling and executing commissioning/validation protocols to ensure equipment/systems are fit for intended use within the laboratory in accordance with appropriate regulatory agency validation requirements, internal company standards and operating procedures, and current industry practices.
Analyze validation/commissioning data, prepare reports, and make recommendations for changes and/or improvements. Investigate and troubleshoot problems and determine solutions. Follow change control principles when assessing changes to equipment/systems.
Maintain and execute an electronic schedule of validation and commissioning activities for laboratory equipment/systems.Complete periodic reviews on laboratory systems and follow up with findings
Assist in generating/compiling standard operating procedures for care and maintenance of laboratory equipment/systems.
Perform additional QA duties, as required, including assisting/supporting daily document management, regulatory affairs, process improvement, and administrative activities.
Bachelor's degree in a biological or clinical laboratory science, or related field
Previous experience operating and maintaining laboratory equipment and computerized systems
Procedures/processes for equipment calibration and maintenance for a laboratory
Working experience with molecular laboratory equipment, including centrifuges, pipettes, heat blocks, thermal cyclers, robotic liquid handlers and sequencing systems used in clinical laboratories
Experience with writing and executing validation and commissioning protocols
Experience with organizing, planning and priotizing commissioning/calibration/maintenance tasks
Experience with performing equipment commissioning, calibration and maintainence activities across multiple quality system requirements, including operating under CLIA/CAP.
Normal Business Hours based on a nine hour workday; availability to provide coverage beyond regular business hours during the week.
Working at Almac Group is exciting, sometimes challenging but always rewarding. Over a period of sustained global growth spanning in excess of 45 years, the diligence and dedication of our 3,700 strong family have made our company the success that it is today. Together we make an invaluable difference to the health of countless patients all over the world - and this is just the beginning!
Be part of something big. Be part of something special. Be part of Almac Group.
Almac Group Ltd. is an Equal Opportunity Employer - Minorities/Women/Protected Veterans/Disabled - Proudly embracing diversity in all of its expressions.