Complaint Investigations

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.

Complaint Intake Support

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

Complaint Investigation Support

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

Return/Retain Examination Support

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

QC Technical Resources Laboratory Support

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