Advanced Sterilization Products is recruiting for a Senior Compliance Auditor to be located in Irvine, CA.
Healthcare-associated infections (HAIs) have a devastating personal and economic impact, claiming the lives of 99,000 people in the U.S. each year at a cost of up to $45 billion. Ensuring that all surgical devices are properly sterilized is one-way healthcare workers can help reduce the incidences of HAIs, and Advanced Sterilization Products (ASP) has been partnering with hospitals for decades to safeguard patient health and safety. ASP has a strong track record of designing and delivering innovative infection-prevention solutions, from low-temperature steam sterilization to high-level disinfection, and is a global market leader setting the standard in sterilization.
Johnson & Johnson announced that it has received a binding offer from Fortive Corporation to acquire Advanced Sterilization Products (ASP). If the offer is accepted, the proposed transaction would be expected to close no later than early 2019, subject to customary closing conditions and regulatory approvals. Should you receive and accept an offer for this position, upon completion of the transaction, your employment with ASP will transfer to Fortive according to local law and will be governed by Fortive’s employment processes, programs, policies and benefits plans.
You, the Senior Compliance Auditor will be responsible for the management of the internal quality audit process and assessment of the company’s activities, as well as collaborate with business partners to ensure compliance to all regulatory and standard requirements. Specific areas of focus will be:
Internal Audits: Establishes, evaluates and maintains the internal audit program that ensures quality management systems are operating in compliance; develops and manages audit plans; conducts audits, develops metrics and compiles data on auditing results, issues or trends and corrective actions and presents to senior management; and develops and delivers required training. Research emerging regulatory trends and changes in regulations and standards to incorporate into the business to ensure ongoing compliance to these requirements.
You, the Senior Compliance Auditor also coordinates and supports requests for directed audits, received from senior management and other customer/business partner groups; supports inspection readiness, external inspections, and other quality and compliance projects; and performs other assigned duties, as needed.
A Bachelor’s degree and a minimum of 4 years in a highly regulated industry, with a strong preference for a medical device, pharma and/or consumer background is required.
4 years of auditing experience is required.
Working Knowledge of 21 CFR Part 820, QSR, ISO 13485, SOR 98-282 CMDR (Canada Medical Device Regulations, J-PAL (Japanese), MDD (European) requirements, and knowledge of Brazil GMP is required.
Certified Quality Auditor (CQA) and/or RABQSA-certified Lead Auditor are preferred.
Proven leadership, teamwork, collaboration and influencing skills; demonstrated initiative assertiveness and strong project management skills are preferred.
Experience supporting microbiology testing and/or reviews is preferred.
Strong computer skills and use of software application(s), including MS Windows, MS Office (Word, Excel, PowerPoint) are required.
Strong written and oral communication skills are required.
Previous experience with Instinct, EtQ is preferred.
This position will be located in Irvine, CA and may require up to 10 % domestic and/or international travel.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
Advanced Sterilization Products (ASP)