Complaint Specialist

Kelly Services® has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a long-term temporary opportunity to work as a Complaint Specialist at a prestigious Fortune 500® company working in Thousand Oaks, CA

 

Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the “Submit Resume” button to submit your resumes. If you have questions about the position, you may contact the recruiter for this position (Brooke.Schoen@kellyservices.com) however your resume must be received via the “Submit Resume” button included within.

 

Job Title: Complaint Specialist   

 

Pay: $37 per hour

 

Primary Role
The Product Quality Surveillance Senior Specialist – Commercial Complaints is an experienced Quality and Technical professional who delivers the Product Quality Surveillance activities for company pipe-line products and appropriate support for in-line products to enable a sustainable existence on the market. 
• Product Quality Surveillance Senior Specialist works closely and collaboratively with the Product Quality Management Leads, Technical Operations and other company functions / stakeholders across the Business to execute product quality surveillance strategies, specifically Product Quality Complaint administration. This includes, but is not limited to Product Quality Complaints and support for the integration of new product acquisitions into post marketing product quality surveillance. 

Responsibilities
Post Marketing Product Quality Surveillance: 
•Provide support to delivery, drive and maintain effective Product Quality Surveillance systems including but not limited to: 
• Effective global Product Quality Compliant Handling 
• Support the provision of metrics regarding key performance indicators of quality from Product Quality Surveillance System in support of the company and Suppliers 
 

Specifically the Complaint Specialist shall: 
•Process global commercial / clinical product Quality Complaints received 
• Assess incoming Product Quality Complaints (PQC) elevating potential issues/ incidents to management, including but not limited to Field alerts, PDRs, BPDRs, MDRs or possible recall situations 
• Assign actions related to each PQC investigation and work with the appropriate Technical and Quality personnel to drive timely delivery of these actions 
• Perform trend analysis on all incoming PQCs and escalate potential risks to management 
• Communicate adverse events reported in conjunction with PQCs to company PVRM 
• Facilitate complaint sample returns (from consumer, pharmacy, healthcare provider or distributor)for inspection / investigation 
• Coordinate pharmacy credits for returned product through company Customer service 
• Coordinate process and review PQC investigations performed at contract site manufacturer / packagers and company site investigations in conjunction with Quality Assurance 
• Evaluate PQC investigation results to ensure adherence to cGMP guidelines and expectations (including device and Combination product cGMPs) in conjunction with technical and quality SMEs as appropriate 
• Generate final correspondence summarizing investigational findings and communicate via letter or fax to complainant / or communicate via the relevant international company QA to ensure local communication requirements are met. 
• Generate reports for management and inspections as required 
• Assist as needed in the preparation of data for internal audits and external audits/ inspections 
• Participate in third party call monitoring to ensure correct communication strategies are being utilized. 
• Assist as needed in preparation and evaluation of complaint summary and trend reports 
 

Essential
• Bachelor’s degree in a relevant scientific/engineering discipline with at least 5 years GMP industry experience, the majority of which has been gained in the QA environment and includes manufacturing related experience. 
• The Senior Specialist will be strong scientifically with technical expertise to ensure robust analysis of complex product data and the ability to assess that information to make scientifically sound quality risk based recommendations. 
• Working knowledge of Regulations, US and EU Regulations, including cGMPs, and GDPs, including knowledge of Controlled substance standards accommodating for example, DEA, IMB, UK Home Office etc. 

Desired
• Strong working knowledge of electronic data management systems (e.g. TrackWise and Veeva) 
• Strong working knowledge of Microsoft Office applications (e.g. Word, Excel, Power Point)

 

 

We invite you to bookmark our Web site and encourage you to review it regularly for new opportunities worldwide: www.kellyservices.com.

Kelly Services® is a U.S.-based Fortune 500 company. With our global network of branch locations, we are uniquely positioned to provide our customers with international staffing support and our employees with diverse assignments around the world.

Kelly Services is an Equal Opportunity Employer

 

 

Why Kelly®?

With Kelly, you’ll have access to some of the world’s highest regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 90 of the Fortune 100 companies and found opportunities for more than 10,000 scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today.

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.

Kelly complies with the requirements of the Fair Chance Initiative. A conviction record does not automatically bar individuals from employment.

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