- 196107 - QA Technician
- Up to $25.00 DOE
- 6 mos
- Chipton-Ross is seeking a QA Technician for an opening in Rochester, NY.
The QA Lab Technician will be responsible for acting as a supporting 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 the Sr. Sterility Assurance Leader. Working closely with R&D Sterilization Leaders and QA Technicians, you will assist them in 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 Sterilization subject matter experts and Packaging subject matter experts: Dose audits, dose setting, sterility validation, re-validations, and package testing. Execute sterility and shelf-life validation documentation such as protocols and reports. Work closely with contract sterilization providers to streamline dose mapping and dose audits.. Assist with the quarterly dose audits (bioburden and sterility testing), annual re-validations, and environmental monitoring. Support customer, notified body, and regulatory audits as needed.
Minimum 1-2 years of microbiology lab experience. Experience in regulated environment preferred (cGMPs, ISO 13485, ISO 9001, etc.). Experience with sterilization of medical devices preferred but not required. Familiarity with ISO, AAMI, ASTM standards relating to sterilization and related topics preferred. Proficient with Microsoft Office. Knowledge of SAP systems preferred.
Accredited Bachelor's degree or equivalent experience.
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 x280 or (800) 927-9318 x280
To ensure compliance with President Biden’s September 9, 2021 executive order, the client is implementing a new requirement for U.S.-based employees to either show proof of being fully vaccinated from COVID-19, or have an approved reasonable accommodation (based on a disability/medical condition or sincerely held religious belief) exempting them from the requirement, by December 8, 2021 (timing may vary in some states). Individuals who are unable to meet COVID-19 requirements due to a disability/medical condition or sincerely held religious belief may apply for a reasonable accommodation during the post-offer process. Individuals with approved accommodations will be subject to frequent COVID-19 testing.
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.