Quality Control Associate

Key Responsibilities:

• Perform inspection and testing of raw materials, in -process, and finished goods.
  
• Document results, complete batch records, and generate QC reports.
  
• Maintain Device History Records (DHR) and ensure compliance with cGMP and regulatory requirements.
  
• Conduct data analysis and support process monitoring and trending.
  
• Investigate Out of Specification (OOS) results and support CAPA activities.
  
• Perform routine maintenance and calibration checks of lab equipment.
  
• Support environmental monitoring and maintain QC lab readiness.
  
• Assist in reagent formulation and manufacturing activities.
  
• Manage lab inventory, supplies, and vendor coordination.
  
• Participate in validations, method development, and process transfers.
  

Quality & Compliance:

• Ensure adherence to FDA, ISO, GMP, and OSHA standards.
  
• Maintain accurate documentation for material handling, storage, and release.
  
• Support audits, safety reporting, and quality system compliance.
  

Qualifications:

• High School Diploma (Associate’s or Bachelor’s in Life Sciences preferred).
  
• 0–7 years of experience in a laboratory or regulated industry.
  
• Experience in cGMP/GLP/ISO environments preferred.
  

Skills & Requirements:

• Strong analytical, troubleshooting, and data analysis skills.
  
• Hands -on lab experience (pipetting, titration, spectroscopy, etc.).
  
• Excellent documentation and organizational skills.
  
• Ability to work in a fast -paced, team -oriented environment.
  
• Familiarity with Lean/6S practices is a plus.
  

Company Benefits: Medical, Dental, Vision, Paid Sick
leave, 401K

If interested, please share your update resume at [email protected]/[email protected]