| Product Monitoring Specialist (85C) |
Job Id: W229306 |
Posted On: 10/22/2009 |
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Location: Stamford, CT;
Job Type: Contract
Salary: $33.00 to $43.00/hr
Degree: Bachelor
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DescriptionRate: $38-$43/hr C2C, $33-38/hr W2
Overview:
Our client is seeking a Product Monitoring Specialist to support processing of product complaints.
Responsibilities:
Review information received on potential product complaints, classify each product complaint by severity and defect type and determine if each meets the criteria
for further processing or initiating an analytical investigation.
Enter complaint information into a validated product complaint database.
Create and maintain a hard copy case file.
Determine if additional information needs to be obtained from the complainant. Specify the questions that need to be asked of the complainant and submit those
questions to the appropriate department to follow up by phone call or letter.
When product samples are to be returned, complete appropriate forms and request applicable letters be sent.
Review requests for product refund or replacement.
Review investigation report and write/review final letter to complainant.
Communicate with the appropriate teams and departments, as warranted by the complainant, to ensure proper processing from receipt through closure.
Adhere to compliance timeframes set in department procedures and the Code of Federal Regulations.
Qualifications:
Bachelors Degree required
Demonstrated experience with product complaint processing (e.g., 2 year experience in a post-marketing Quality position or Drug Safety position wherein product
complaints were processed in one or more aspects documented, data entered, investigated, cases monitored.
Knowledge of definition of Field Alert, GMPs, understanding of due diligence; data entry into data bases and understanding of what an investigation includes).
Product complaint processing experience (for example, 6 months - 2 years experience in a Quality Assurance department covering product complaints within a pharmaceutical manufacturing environment; 6 months - 2 years experience in processing product complaints and/or ensuring that products meet specification in accordance with Good Manufacturing Practice (GMP); 6 months -2 years in a Drug Safety or Product Complaint position wherein product complaints were processed in one or more respects [documented, data entered, investigated, cases monitored].
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