Quality Engineer

Responsibilities

• Support quality engineering activities for manufacturing and lab operations, including deviation investigations, CAPA, change control, and validation.
• Review batch records, SOPs, technical documents, and quality reports to ensure compliance with GMP, cGMP, and GLP standards.
• Absorb method development support, qualification activities, and validation documentation review for processes, equipment, and laboratory systems.
• Collaborate with QA, QC, Manufacturing, Validation, and Engineering teams to resolve quality issues and improve compliance.
• Participate in root cause investigations for deviations, out-of-trend results, and process issues.
• Support equipment qualification, calibration reviews, and maintenance documentation.
• Review and assess change control requests related to procedures, equipment, materials, and processes.
• Maintain accurate and compliant quality documentation and records.

Requirements

• Support quality engineering activities for manufacturing and lab operations, including deviation investigations, CAPA, change control, and validation.
• Review batch records, SOPs, technical documents, and quality reports to ensure compliance with GMP, cGMP, and GLP standards.
• Absorb method development support, qualification activities, and validation documentation review for processes, equipment, and laboratory systems.
• Collaborate with QA, QC, Manufacturing, Validation, and Engineering teams to resolve quality issues and improve compliance.
• Participate in root cause investigations for deviations, out-of-trend results, and process issues.
• Support equipment qualification, calibration reviews, and maintenance documentation.
• Review and assess change control requests related to procedures, equipment, materials, and processes.
• Maintain accurate and compliant quality documentation and records.

Qualifications

• Support quality engineering activities for manufacturing and lab operations, including deviation investigations, CAPA, change control, and validation.
• Review batch records, SOPs, technical documents, and quality reports to ensure compliance with GMP, cGMP, and GLP standards.
• Absorb method development support, qualification activities, and validation documentation review for processes, equipment, and laboratory systems.
• Collaborate with QA, QC, Manufacturing, Validation, and Engineering teams to resolve quality issues and improve compliance.
• Participate in root cause investigations for deviations, out-of-trend results, and process issues.
• Support equipment qualification, calibration reviews, and maintenance documentation.
• Review and assess change control requests related to procedures, equipment, materials, and processes.
• Maintain accurate and compliant quality documentation and records.

Skills

• Support quality engineering activities for manufacturing and lab operations, including deviation investigations, CAPA, change control, and validation.
• Review batch records, SOPs, technical documents, and quality reports to ensure compliance with GMP, cGMP, and GLP standards.
• Absorb method development support, qualification activities, and validation documentation review for processes, equipment, and laboratory systems.
• Collaborate with QA, QC, Manufacturing, Validation, and Engineering teams to resolve quality issues and improve compliance.
• Participate in root cause investigations for deviations, out-of-trend results, and process issues.
• Support equipment qualification, calibration reviews, and maintenance documentation.
• Review and assess change control requests related to procedures, equipment, materials, and processes.
• Maintain accurate and compliant quality documentation and records.

Benefits

• Support quality engineering activities for manufacturing and lab operations, including deviation investigations, CAPA, change control, and validation.
• Review batch records, SOPs, technical documents, and quality reports to ensure compliance with GMP, cGMP, and GLP standards.
• Absorb method development support, qualification activities, and validation documentation review for processes, equipment, and laboratory systems.
• Collaborate with QA, QC, Manufacturing, Validation, and Engineering teams to resolve quality issues and improve compliance.
• Participate in root cause investigations for deviations, out-of-trend results, and process issues.
• Support equipment qualification, calibration reviews, and maintenance documentation.
• Review and assess change control requests related to procedures, equipment, materials, and processes.
• Maintain accurate and compliant quality documentation and records.

Pay

Competitive salary commensurate with experience.

Schedule

Full-time position.