Complaint Sample Processing Associate

Job Summary

We are seeking a detail-oriented and organized Complaint Sample Processing Associate to support complaint sample intake, documentation, examination, and retention sample management activities. This is an entry-level position suitable for candidates with basic laboratory experience or an interest in quality and laboratory operations.

The individual will receive and process returned complaint samples, perform initial visual examinations, capture photographic evidence, document sample information, and record observations in the Laboratory Information Management System (LIMS). The role also involves preparing complaint samples for destruction and examining regulatory retention samples to document their condition.

This position focuses primarily on sample handling, visual observation, accurate documentation, and adherence to established procedures. Advanced laboratory testing, analytical techniques, and specialized technical expertise are not required.

Key Responsibilities

1. Complaint Sample Receipt and Processing

• Receive returned complaint samples and verify the accompanying documentation.
• Perform initial checks to confirm sample identification and ensure the samples match the information provided.
• Record sample details, including identification numbers, descriptions, condition, and other relevant intake information.
• Inspect samples for visible damage, abnormalities, missing components, or other noticeable characteristics.
• Organize and manage incoming complaint samples in accordance with established procedures.
• Ensure samples are properly identified, labeled, and stored in designated areas.

2. Visual Examination and Documentation

• Conduct basic visual examinations of returned complaint samples to identify readily observable characteristics.
• Capture photographs of complaint samples to provide supporting evidence for complaint investigations.
• Document sample conditions, physical appearance, packaging condition, and other relevant observations.
• Enter sample information, observations, and photographic evidence into LIMS.
• Ensure all records are accurate, complete, and entered in a timely manner.
• Escalate missing information, damaged samples, or unusual observations to the appropriate team member.

3. LIMS Data Entry and Record Management

• Enter complaint sample intake details and examination observations into the Laboratory Information Management System (LIMS).
• Maintain accurate electronic records associated with complaint samples and regulatory retention samples.
• Verify that entered information matches the sample identification and available documentation.
• Upload or associate photographs and supporting evidence with the appropriate sample records.
• Follow established documentation practices and standard operating procedures (SOPs).
• Maintain data accuracy, traceability, and confidentiality of complaint-related records.

4. Complaint Sample Destruction

• Process complaint samples designated for destruction in accordance with approved procedures.
• Verify sample identification and destruction authorization before initiating processing.
• Update the relevant documentation and LIMS records to reflect the sample disposition.
• Coordinate with the appropriate personnel to ensure samples are handled and disposed of according to established requirements.
• Maintain records confirming completion of the sample destruction process.

5. Regulatory Retention Sample Examination

• Retrieve and examine regulatory retention samples as assigned.
• Perform basic visual checks to assess the general condition and appearance of retained samples.
• Record observations, sample identification details, and any noticeable changes in LIMS.
• Capture photographs when required by established procedures.
• Ensure retention sample records are complete, accurate, and traceable.
• Report missing, damaged, or unusual retention samples to the appropriate supervisor.

6. Quality and Compliance

• Follow applicable SOPs, documentation requirements, and sample-handling procedures.
• Maintain an organized work area and ensure samples are stored in designated locations.
• Adhere to applicable Good Documentation Practices (GDP) and relevant quality system requirements.
• Support complaint-handling and quality operations through accurate sample documentation.
• Communicate discrepancies or incomplete records promptly to the supervisor or complaint-handling team.
• Complete assigned training and follow all applicable safety and quality procedures.

Required Qualifications

• High school diploma or equivalent required; an associate degree or bachelor's degree in a science-related field is preferred.
• Entry-level candidates are encouraged to apply.
• Basic computer skills and the ability to enter and maintain accurate records.
• Strong attention to detail and the ability to follow written instructions.
• Good organizational skills and the ability to manage multiple samples and documentation tasks.
• Basic written and verbal communication skills.
• Ability to perform routine sample-handling and documentation activities.

Preferred Qualifications

• Previous laboratory, sample management, quality assurance, or quality control experience is a plus.
• Familiarity with LIMS or other electronic documentation systems is beneficial.
• Exposure to pharmaceutical, biotechnology, medical device, or other regulated environments is an advantage.
• Basic understanding of SOPs, sample traceability, and Good Documentation Practices (GDP) is preferred but not mandatory.