Kelly Services REGULATORY AFFAIRS QUALITY CONTROL OFFICER in Ocean Springs, Mississippi
Kelly seeks a detail orientated Regulatory Affairs Quality Control Officer. Apply today.
Review and process emails daily regarding regulatory or quality concerns and notify managers or other departments as necessary. Ensure timely and effective communication and follow-up with customers and manufacturers as necessary.
Maintain all vendor and customer files, ensuring that all licenses are reviewed annually, and records are maintained and available for regulatory audits.
Under guidance of regulatory manager, ensure strict adherence to U.S. government agency rules and regulations as well as country-specific importing/exporting policies and regulations.
Maintain knowledge of Good Distribution Practices; assist Regulatory Affairs Manager with GDP compliance.
Assist in maintenance, upkeep, and updating of company Standard Operating Procedures, as needed, and to facilitate company compliance program.
Assist in daily, weekly, monthly or annual audits as directed by the Regulatory Affairs Manager.
Process and accurately complete any required regulatory documentation (COA, TSE, Declaration Certificates, Quality Complaints, Technical Inquiries, MSDS, Stability Requests, etc.) according to company policy and any government regulations. Maintain all documentation and files.
Perform internal audits, to include in-process inspections of product handling (Controlled Drug, HazMat, Cold Chain, etc.), product packing, and product documentation.
Complete and verify Controlled Drug processing documentation for shipment, following all government regulations.
Handle important product information changes and label changes (NDC#, country of origin, etc.). Update product files and notify appropriate personnel.
Handle and process all product quality notices from regulatory agencies (recalls, warning letters, etc.), following company standard operating procedures and management directives.
Monitor warehouse temperature monitoring and maintain all documentation.
In coordination with operations manager, oversee product destruction and handle controlled drug product destruction. Maintain all product destruction records.
Audit controlled drug job jackets to ensure that proper documentation is maintained per DEA regulations.
Any other duties assigned by your Manager
Graduate, High School Diploma or GED. Some college preferred.
Minimum 2 years- experience in regulatory, compliance, quality assurance, pharmaceuticals or some other related field.
Excellent oral and written communication skills
Proficiency with Microsoft Office Suite
Ability to multitask
Attention to detail; organizational skills
Self-starter with ability to work independently
Forward-thinking and open-minded
Strong problem solving and analytical skills
Adaptability and versatility in a dynamic environment
Ability to effectively work in a team environment while maintaining group morale and mutual respect
Positive attitude and strong work ethic
This employment opportunity is being sourced by a remote recruiter. For immediate consideration apply through this job post or send resume to mart717@Kellyservices.com with subject "regulatory"
Why Kelly ® ?
As a worker today, it’s up to you to take charge of your career and look for opportunities to learn, grow, and achieve your potential. Helping you find what’s next is what we’re all about. We know what’s going on in the evolving world of work—just ask the 440,000 people we employ each year. Connecting with us means getting the support, guidance, and opportunities needed to take your career where you may have never imagined.
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. 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.