Product Complaints

SmartRecruiters, Inc.; New Brunswick (NJ); On-site; USD 55,000 - 75,000; Full time

Job summary

SmartRecruiters, Inc. is seeking a QA/compliance-focused Laboratory Specialist in New Jersey to manage quality complaints from the call center. You will enter PQC data into the QA database, secure product samples, coordinate replacements or reimbursements, and perform lab evaluation of returned products.

The role emphasizes documenting investigations, identifying complaint trends, and supporting metrics. Prior lab or QA/QC experience and familiarity with complaint processing are required;

Qualifications

• Experience handling PQC data entry from call centers.
• Laboratory or QA/QC experience in medical devices preferred.
• Strong communication and documentation skills required.

Responsibilities

• Enter PQC information accurately into QA database from the call center.
• Notify customers/stakeholders to ensure information accuracy.
• Identify non-PQC returns and route them to the appropriate area.
• Escalate complaints requiring expedited review to sites and senior management.
• Communicate with complainants to obtain samples and clarify the complaint.
• Document communications and letters to file as appropriate.
• Manage product sample mailers and facilitate resolution of mailer issues.
• Perform laboratory evaluation of customer-returned products and write evaluation reports.
• Complete document-based investigations in the QA database.
• Identify trends and report performance metrics for complaint processing.
• Handle areas involving laboratory waste and bloodborne pathogens.

Skills

PQC processing

QA/QC experience

Laboratory experience

Customer communication

Tools

TrackWise

Job description

Job Description

Laboratory experience in a complaint management or QA/QC role required. Experience with medical devices preferred.11. Experience in TrackWise preferred but not required

Responsible for capturing and recording product quality complaints (PQC) from call center into Quality Assurance (QA) database. Direct communication with complainants to secure product complaint samples and provide information about the product required for the investigation. Manage product replacement and/or reimbursement. Perform laboratory evaluation of customer-returned product. Process document-based investigations. Assist to identify and report complaint trends. Assist to define and track performance metrics.

1. As complaint information is received from the call center, enter accurately into QA database. If incorrect information is received, notify the appropriate customer/stakeholder to ensure information is accurate.


2. Assist to identify non-PQC’s which are returned to the originator with the reason why it is not a PQC and forwarded to the appropriate functional area, or tracked, as required.


3. Assist to identify complaints which require expedited review and are escalated to the sites and senior management immediately.


4. Communicate directly with complainant to secure product complaint samples and obtain more information/clarity about the complaint.


5. Clearly document communication with complainant in acknowledgement letters to complainant or "letters to file" as appropriate.


6. Communicate complaint issues requiring Legal involvement to management.


7. Manage product sample mailers to complainant. Address/facilitate resolution of issues associated with the mailer package.


8. Manage product replacement and/or reimbursement.


9. Perform laboratory evaluation of customer-returned products and write evaluation report.


10. Perform document-based investigation in the QA database.


11. Finish complaints in the QA database and send final letters to complainant explaining the outcome of the investigation if required.


12. Assist to identify and report complaint trends by analyzing the data in the QA database.


13. Assist to define and track performance metrics to assure compliance processing complaints.


14. Required to enter and work in areas responsible for the handling of laboratory waste and blood borne pathogens.

Qualifications

Demonstrated experience with complaint processing" (especially customer-facing activities).

Additional Information

This job is with one of my Medical/Pharma Client.