21 days old

Product Compliance Specialists

Kelly Services
Santa Ana, CA 92702
**Title: Product Compliance Specialists**

**Location: Santa Ana, CA**

**Pay: Competitive**

**Day Shift: Monday-Friday**

**THE COMPANY is a worldwide leader in the innovation and manufacture of cell culture media, reagents, and medical devices for researchers and clinicians. The company provides unrivaled service and quality to scientists working in biopharmaceuticals, cell therapy, and regenerative medicine, assisted reproductive technology and cytogenetics, and industrial cell culture for the large-scale production of biotherapeutics and vaccines.**

**THE COMPANY adheres to both ISO and FDA regulations and operates dual cGMP manufacturing facilities in California, USA, and Tokyo, Japan. The companys consultative philosophy combined with expertise in cell culture and compliance provides customers with unique capabilities and support. For over 50 years, THE COMPANY remained uniquely flexible and focused on media while becoming a strategic global leader in media products and services.**

**We are hiring a Product Compliance Specialist.**

**The Product Compliance Specialist performs, executes and manages Quality System product compliance tasks related to Complaints, CAPA, Quality Planning, and Facility Change Requests (FCRs). Manage customer complaint process, including but not limited to, complaint intake, documentation and investigation, customer follow-up, tracking and trending. Lead and manage complaints investigations internally and communicate directly with customers. Lead and manage CAPA investigations, Quality Planning and FCRs.**


**Manage and perform product Compliance activities, including, but not limited to, the following:**

+ **CAPA initiation, closure and investigation support of assigned CAPA owners**

+ **Review and planning for Facility Change Requests (FCR)**

+ **Writing, review and closure of Quality Planning Activities among all sites**

+ **Complaint documentation intake, investigation oversight, customer follow-up, tracking and trending**

+ **Determine the nature of direct and indirect customer inquiries, and classify them for resolution.**

**Managing and monitoring customer inquiries associated with complaints or CAPAs. Managing and coordinating cross-functional activities for Compliance activities.**

+ **Ensuring timely and accurate closure of customer complaints, CAPAs, FCRs and Quality Planning activities and that established turnaround times are met.**

+ **Ensuring compliance of processes and procedures to applicable standards related to Compliance activities, including but not limited to, complaints, CAPAs, FCRs and Quality Planning.**

+ **Assisting in the communication with regulatory agencies, notified body, and competent authorities as associated with Compliance activities.**

**Experience/ Education:**

+ **B.S. or B.A. in scientific discipline preferred.**

+ **wo (2) or more years of experience in Quality Assurance/Regulatory Affairs/Compliance, technical and customer support in a medical device discipline.**

+ **GMPs, CFRs, USP, ISO 13485, CMDR, MDD 93/42/EEC, IVD D 98/79/EC, ISO harmonized standards (EN14971, EN 13408, EN 13824).**

+ **Quality control methodology, QA control systems and production methodologies.**

+ **Experience in cell and tissues culture. Experience can be from education or industry.**

**Ability to obtain cooperation from other groups and lead cross functional teams.**

+ **Experience with risk management and Failure Mode Effects Analysis (FMEA).**

+ **Strong root cause analysis skills required.**

+ **Ability to speak, read and write English proficiently.**

+ **Good oral and written communication skills**

+ **Proficient in Microsoft Word, Excel, PowerPoint, Outlook.**

**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.

**Why Kelly** **** **?**

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (
Posted: 2022-07-22 Expires: 2022-08-22

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Product Compliance Specialists

Kelly Services
Santa Ana, CA 92702

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