Quality Control Specialist
On-siteMonroe Township, New Jersey, United States
Job Summary
Support daily QC activities across production areas including assembly, pouching, labeling, and packaging. Perform and verify line clearance, equipment checks, and in-process inspections while recording and reviewing production and QC testing data in Device History Records (DHRs) in real time. Conduct AQL inspections and sampling on finished products as required, identify and report non-conformances, and assist in root cause analysis. Maintain organized records and ensure data archiving in accordance with SOPs. Assist in training new QC personnel and support cross-functional communication with production teams. Requires five years of experience in a GMP-regulated environment, proficiency in Microsoft Office, and bilingual English and Korean skills.
Required Qualifications
- 05 years of experience in Quality Control or Quality Assurance within a GMP-regulated manufacturing environment
- Bachelors degree in Biology, Chemistry, or a related scientific/engineering field
- Bilingual in English and Korean
- Strong attention to detail and documentation accuracy
- Ability to work independently and as part of a team in a fast-paced environment
- Excellent time management and problem-solving skills
- Proficiency in Microsoft Office (Word, Excel)
- Communicate effectively in both English and Korean
Desired Qualifications
- Experience in medical device, pharmaceutical, or diagnostics industry
- Working knowledge of ISO 13485, GMP, and FDA quality regulations
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