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
Click
here to apply!
|