Sr. Quality Assurance Specialist

---

Job description

Kelly Science is looking for an experienced candidate in the area of Quality Assurance. This is a direct hire opportunity.

**Sr. Quality Assurance Specialist, Santa Fe Springs**

**Support the Company's Quality Assurance Initiative and be responsible for FDA, NACD, and ISO compliance.**

+ Develops and maintains the Company's Quality Systems including the Quality Statement and Quality Manual, with responsibilities including document control procedures; management of controlled documents, collecting, formatting, authoring, and approving Standard Operating Procedures SOPs and managing the customer complaint process including Root Cause Analysis RCA , and the associated Corrective Action/Preventative Action CAPA process.

+ Ensuring the Company's ongoing compliance with procedures and requirements for FDA. This involves compliance with 21 CFR CFR 211, implementing product label control process, maintaining FDA product and establishment registrations, and conducting tests of FDA products when issues arise.

**Functions Managed by this Position:**

+ Maintains Biannual Drug Manufacturing License Renewals

+ Ensure the Company's Compliance with 21 CFR CFR 211 cGMP Requirements Including Training, Procedures, Equipment, and Instruments Validations, and Generating Associated Documentation

+ Authors All FDA-Related SOPs

+ Completes ESG Product Registrations Annually

+ Conducts Internal Supplier Audits

+ Leads the Company's Recall Program Including Lot Traceability and Conducts Mock Recalls

+ FDA Audits

+ Document Product Label Control

+ Training Continuous Improvement NACD Compliance

+ Leads Coordinates the Company's NACD Initiative

+ Ensures Compliance with all Aspects of the NACD Program

+ Point of Contact for All NACD-Related Communication

+ Implements Active Program with 13 Codes of Management Practices

+ Leads Internal Auditing Processes

+ Hosts NACD-Related Audits Inspections CAPA Non-Conformance Resolution

+ Leads Investigation into All Customer Complaints as it Pertains to cGMP Compliance

+ Initiate, Manage and Resolution of Non- Conformance, RMA, and implementation of CAPA Process

**Desirable Attributes:**

Communication

+ Writes and Speaks professionally, fluently, clearly and concisely

+ Effective and Confident Communicating in a Variety of Settings Both Inside and Outside of the Organization

+ Creates Professional, Accurate and Effective Reports, Documents, Procedures and Other Communications Technical Skills

+ Demonstrates Strong Technical Skills and Thorough Understanding of Laboratory Practices Procedures, Methods, Validation, Production and Engineering.

+ Provides Technical Assistance to Area Supervisors or Managers Helping to Solve Complex Problems

+ Answers Technical and Procedural Questions Based on cGMP Regulations and SOPs, and Provides Advice and Guidance to Operations Personnel

+ Skills including - Investigating, Interviewing

**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 interests-it's 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, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're 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. ()