Complaint Investigator

Company: Actalent
Location: Deerfield Beach
Posted on: May 14, 2022

Job Description:

Description:

The incumbent will conduct and document product complaint investigations. Investigations will be completed through the review of manufacturing records and associated deviations, examination of returned complaint samples, coordination of product reserve sample evaluation, and review of complaint histories and trends. The incumbent will track all product complaint investigations and assigned complaint categories. Where possible, the root cause of the complaint and corrective actions will be identified. Upon completion of these activities a final report will be prepared in accordance with established procedures. List of Responsibilities: Understand customer / patient use of and manufacturing processes for site manufactured, packaged and/or distributed products. Track receipt, investigation and closure of product complaints to ensure adherence to established timelines. Investigate complaints and subsequently document the evaluation actions taken and conclusions reached using the defined report template. Where possible identify the root cause of the complaint and facilitate identification and implementation of corrective and preventive actions relative to a complaint investigation. Track and trend complaints, including provision of trend reviews / reports to customers, site and corporate management, and for Annual Product Records Reviews. Assure regulatory compliance of the complaint program is maintained. Perform periodic reviews of program-related SOPs / processes and revise as necessary. When required, perform / document a assessment to assure alignment of site SOPs / processes requirements; close identified gaps through SOP revision or other actions. Support / conduct of internal and external cGMP audits and regulatory agency inspections, and completion of post-audit / inspection commitments. Support operations and quality management initiatives and objectives.

Skills:

complaint handling, investigations, root cause analysis, document control, record keeping, gmp, pharmaceutical, sop, fda, documentation review, product safety, complaint analysis, medical device, capa

Top Skills Details:

complaint handling,investigations,root cause analysis,document control,record keeping,gmp,pharmaceutical,sop,fda,documentation review

Additional Skills & Qualifications:

Must: -3+ years experience in areas of Complaint investigations, or post market surveillance, or Investigations and Root Cause Analysis -Pharma or medical device industry (cGMP, FDA, GDP ) -Able to do heavy customer interaction Plus: -Device based -Bachelor degree in Science or Engineering -Complaint Investigations

Experience Level:

Expert Level

About Actalent:

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We're supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

Keywords: Actalent, Deerfield Beach , Complaint Investigator, Other , Deerfield Beach, Florida