- 193694 - Quality Assurance Specialist
- Up to $25.00 DOE
- 4 mos
- Chipton-Ross is seeking a Quality Assurance Specialist for an opening in Rochester, NY.
Under the direction of R&D Research Manager, the Sterility Assurance Technician will be responsible for acting as a core team member in projects involving radiation (gamma and e-beam) and ethylene oxide sterilization of commercial laboratory consumables, including medical devices.
You will report to R&D and support Manufacturing Operations / Supply Chain as needed. Working closely with Sterility Assurance Leaders you will assist them in developing and executing our sterilization strategy. You will also work closely with sterilization suppliers, technicians, engineering, project managers, product managers, and packaging engineers to ensure that the product specific sterilization processes are properly validated and documented. This role will need to have effective time management and multi-tasking skills and have a team player mindset.
Support our Sterility Assurance subject matter experts: New product introductions; New supplier qualifications; Test plans for product and/or process changes affecting sterile products. Execute sterility and shelf-life validation documentation such as protocols and reports. Work closely with contract sterilization providers for routine sterilization process development
Assist with the review quarterly dose audits and annual re-validations. Support customer, notified body, and regulatory audits as needed.
Minimum 2 years related sterilization experience, must include ebeam. Experience in regulated environment (cGMPs, ISO 13485, ISO 9001, etc.) Experience with sterilization of medical devices. Familiarity with ISO, AAMI, ASTM standards relating to sterilization and related topics.
Accredited Bachelor’s degree
Employment will be contingent on clearing a drug screen and background check. Both must clear prior to start date.
420 Culver Boulevard
Playa Del Rey, CA 90293
Phone: (310) 414-7800 x307 or (800) 927-9318 x307
Candidates responding to this posting must currently possess the eligibility to work in the United States. No third parties please.
Employment will be contingent on candidate clearing pre-employment drug screen and background check.
Chipton-Ross provides equal employment opportunities to all employees and applicants for employment without regard to race, color, creed, religion, national origin, sex (including pregnancy), age, disability, sexual orientation, gender identity and/or expression, protected veteran status, genetic information, or any other characteristic protected by Federal, State or local law. This policy governs all areas of employment at Chipton-Ross, including recruiting, hiring, training, assignment, promotions, compensation, benefits, discipline, and terminations.