Quality Control (QC) Sample Evaluation Associate

Job Summary

We are seeking a detail-oriented Quality Control (QC) Sample Evaluation Associate to support the evaluation and investigation of returned product samples associated with customer complaints. The individual will conduct hands-on laboratory evaluations, functional testing, and visual examinations to help confirm reported product defects and identify potential root causes. This role plays an important part in product quality investigations and reportability assessments by providing objective evidence to determine whether a reported issue may be related to the manufacturing process. General laboratory experience is preferred, and experience in a Good Manufacturing Practices (GMP) environment is a plus.

Key Responsibilities

• Receive, handle, and evaluate returned product samples associated with customer complaints and quality issues.
• Perform hands-on laboratory examinations to assess reported product defects and determine whether the observed condition can be confirmed.
• Conduct functional testing on returned products to evaluate performance and identify potential failures or abnormalities.
• Perform visual inspections and basic microscopy or imaging evaluations to document product defects, physical damage, or irregularities.
• Compare returned samples against product specifications, acceptance criteria, reference samples, or other applicable quality standards.
• Record observations, test results, and supporting evidence accurately and objectively.
• Capture photographic evidence and images of identified defects to support complaint investigations and technical assessments.
• Assist Quality and Manufacturing teams in evaluating potential manufacturing-related causes of reported product issues.
• Review sample evaluation findings to identify patterns, recurring defects, or potential trends that may require further investigation.
• Provide laboratory findings and supporting documentation for product complaint investigations and reportability assessments.
• Support root cause investigations by supplying relevant test results, observations, and objective evidence.
• Identify potential Corrective and Preventive Action (CAPA) opportunities based on recurring issues or findings from returned sample evaluations.
• Maintain accurate laboratory records in accordance with applicable documentation practices and quality procedures.
• Follow established laboratory procedures, sample handling requirements, and safety guidelines.
• Maintain the organization and cleanliness of laboratory work areas and ensure samples are handled appropriately throughout the evaluation process.
• Collaborate with QC, Quality Assurance (QA), Manufacturing, and Complaint Investigation teams to support timely completion of investigations.

Required Qualifications

• High school diploma or equivalent required; an associate degree or bachelor's degree in a scientific or technical discipline is preferred.
• General laboratory experience involving sample handling, product examination, testing, or documentation.
• Experience performing functional testing, visual inspections, microscopy, or imaging of products or components.
• Strong attention to detail and the ability to identify, observe, and document product abnormalities.
• Ability to follow written procedures, work instructions, and established testing methods.
• Strong written communication and recordkeeping skills.
• Ability to work independently while collaborating effectively with cross-functional teams.