Bioanalytical QA Specialist — GLP/GCP Compliance

TriApex Laboratories Co., Ltd.; North Wales (Montgomery County); On-site; USD 70,000 - 100,000; Full time

Job summary

TriApex Laboratories USA is seeking a detail-oriented QA Specialist to support quality and compliance activities in our bioanalytical laboratory in the United States. The role focuses on maintaining the Quality Management System, conducting audits, and ensuring data integrity.

You will review regulated documents, manage SOPs, and assist with regulatory inspections, CAPA, and deviation investigations while working with scientific and operations teams.

Qualifications

• Bachelor's degree in biology, chemistry, pharmaceutical sciences, biotechnology, or related field.
• 2–5 years of QA, QC, bioanalytical, or regulated-lab experience.
• Working knowledge of GLP and applicable regulatory requirements.
• Experience in CRO/pharma/bioanalytical labs preferred.

Responsibilities

• Support implementation and maintenance of the laboratory QMS.
• Perform QA reviews and audits of regulated studies, processes, data, and reports.
• Conduct facility, process, and study inspections per QA procedures.
• Monitor GLP/GCP compliance with SOPs, study plans, and protocols.
• Document audit observations and track resolutions.
• Support regulator and client inspections and readiness.
• Coordinate preparation, review, approval, issuance, revision, and periodic review of SOPs and controlled documents.
• Ensure training documentation is complete and properly documented.

Skills

Detail-oriented

Documentation skills

Time-management

Communication skills

Education

Bachelor's degree in life sciences

Job description

TriApex Laboratories USA is seeking a detail-oriented QA Specialist to support quality and compliance activities in our bioanalytical laboratory in the United States. The role focuses on maintaining the Quality Management System, conducting audits, and ensuring data integrity.

You will review regulated documents, manage SOPs, and assist with regulatory inspections, CAPA, and deviation investigations while working with scientific and operations teams.