Quality Assurance Specialist

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 and highly accountable Quality Assurance (QA) Specialist to support quality and compliance activities for our Bioanalytical laboratory.

The QA Specialist will support the implementation and maintenance of the laboratory Quality Management System (QMS), conduct study and facility audits, review regulated documentation and data, manage SOPs and quality records, and help ensure compliance with applicable GLP/GCP requirements and company procedures.

This is a hands-on position requiring strong attention to detail, organization, independent judgment, and the ability to manage multiple priorities in a growing laboratory environment.

Key Responsibilitie:

Quality Assurance & Compliance

• Support implementation and maintenance of the laboratory QMS.
• Perform QA reviews and audits of regulated bioanalytical studies, processes, data, and reports.
• Conduct facility, process, and study-based inspections according to established QA procedures.
• Monitor compliance with applicable GLP/GCP requirements, SOPs, study plans, protocols, and laboratory procedures.
• Document audit observations and track findings through appropriate resolution and closure.
• Support regulatory and client inspections, audits, and inspection-readiness activities.

SOP & Document Management

• Coordinate preparation, review, approval, issuance, revision, and periodic review of SOPs and controlled documents.
• Maintain accurate and current quality records and document-control systems.
• Ensure obsolete documents are appropriately controlled and archived.
• Support training documentation and ensure required training is completed and properly documented.

Study & Data Quality

• Review study documentation, raw data, analytical records, and reports for completeness, accuracy, traceability, and compliance.
• Support quality oversight of bioanalytical activities, including ligand-binding assays, LC-MS/MS, biomarker assays, immunogenicity assays, and other laboratory activities.
• Verify that deviations, investigations, and corrective actions are appropriately documented and resolved.
• Promote ALCOA+ principles and strong data-integrity practices throughout the laboratory.

Quality Systems

• Support deviation, CAPA, change-control, and investigation processes.
• Track quality metrics, observations, CAPAs, training, and other quality-system activities.Assist with equipment, computerized-system, and vendor qualification activities from a QA perspective.
• Support laboratory archive and record-retention activities.
• Identify opportunities to improve quality systems, compliance, and operational efficiency.

Qualifications

• Bachelor's degree in biology, chemistry, pharmaceutical sciences, biotechnology, or a related scientific discipline.
• 2-5 years of QA, QC, bioanalytical, pharmaceutical, CRO, or regulated laboratory experience preferred.
• Working knowledge of GLP and applicable regulatory requirements.
• Experience in a CRO, pharmaceutical, biotechnology, or bioanalytical laboratory environment strongly preferred.
• Familiarity with bioanalytical laboratory operations and regulated documentation.
• Experience with SOPs, deviations, CAPA, audits, document control, and/or training systems preferred.
• Strong attention to detail and documentation skills.
• Excellent organizational and time-management skills.
• Ability to manage multiple priorities and follow activities through to completion.
• Strong written and verbal communication skills.
• Ability to work independently while collaborating effectively with scientific and operational teams.