Complaint Investigations (Multiple Opportunities)

Job Description

Propharma has multiple opportunities for the following positions. These are contract opportunities lasting 12+ months in duration. They are a mix of remote and on-site roles.

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Complaint Intake Support

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• Intake of Product Complaints
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• Monitors group mailbox for correspondence from Call Center
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• Evaluates correspondence to determine if the reported information is a new event, additional information to an existing event, or duplicate information to an existing event
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• Enters information into the Quality Management System (EQMS)
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• Evaluates information to determine if an event meets criteria of a complaint (PTC); if so, assigns Risk Level, directly influencing Regulatory Reporting
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• Corresponds with personnel and contractors (Call Center, Clinical Trial Management, etc.) as required to request or obtain additional information related to complaint reports
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• Moves the record in EQMS to the next stage
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Complaint Investigation Support

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• Investigation of Product Complaints
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• Conducts product complaint investigations to identify potential root causes and CAPA opportunities
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• Evaluates batch records for potential contributing factors for established complaint categories
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• Investigates complaint trend excursions
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• Submits investigation extensions in EQMS when required
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Return/Retain Examination Support

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• Product Returns/Retention Samples
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• Receives and processes returned complaint samples
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• Examines complaint samples, obtains photographic evidence, records sample data, and enters observations and evidence in LIMS
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• Processes complaint samples for destruction
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• Examines regulatory retention samples and records observations in LIMS
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QC Technical Resources Laboratory Support

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• Conducts evaluation of returned samples to aid in confirmation of reported defects and determination of potential root cause and CAPA opportunities
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• QC sample evaluation is a critical component of reportability assessments, helping determine whether there is evidence of a potential manufacturing-related root cause
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