Overview
On Site
USD 65,000.00 - 85,000.00 per year
Full Time
Skills
MI
Marketing Intelligence
Management
SAP BASIS
Quality Audit
Documentation
Standard Operating Procedure
Training
Corrective And Preventive Action
Process Improvement
Computerized System Validation
Backup
Science
Communication
Law
Quality Assurance
GLP
Life Sciences
Regulatory Compliance
Auditing
Inspection
Job Details
Piper Health & Sciences is seeking a Quality Assurance (QA) Auditor to join a life sciences organization in the Muskegon, MI area on a full-time, direct hire basis. This position supports quality auditing activities for various GLP/preclinical studies.
Responsibilities for the QA Auditor include:
Ensure GLP studies comply with protocols and regulations, with proper documentation.
Audit protocols, amendments, in-process phases, and study reports for GLP/Method Validation studies.
Act as lead QA for multi-site studies and maintain the Master Schedule.
Conduct audits (facility, process-based) and review Standard Operating Procedures (SOPs).
Provide regulatory training and host/liaise with regulatory agencies during audits.
Support supplier qualifications, track deviations/audit findings, and lead CAPA/process improvement projects.
Assist with CSV activities, serve as backup archivist, and handle other assigned tasks.
Qualifications for the QA Auditor include:
Bachelor's degree in life sciences, animal science, or similar field is required at minimum.
5+ years of QA experience in preclinical GLP studies preferred.
Strong communication skills and understanding of protocols, GLPs, and laboratory operations.
RQAP certification (preferred).
Compensation for the QA Auditor includes:
Salary Range: approximately $65,000 - $85,000 annually, commensurate with experience
Comprehensive Benefits: Medical, Dental, Vision, 401k, PTO, Paid Holidays, Sick leave as required by law
This job is open for applications on 5/2/2025. Applications for this role will be accepted at least 30 days from the posting date.
Senior qa auditor, quality assurance auditor, qa, glp, good laboratory practices, preclinical, life sciences, in vivo, in vitro, animal studies, cqa, rqap, method validation, regulatory, compliance, audit, inspection, fda, food and drug administration, iacuc, veterinary medicine, vaccine, therapeutics, biotherapeutics, bioservices
#LI-CP1
#LI-ONSITE
Responsibilities for the QA Auditor include:
Ensure GLP studies comply with protocols and regulations, with proper documentation.
Audit protocols, amendments, in-process phases, and study reports for GLP/Method Validation studies.
Act as lead QA for multi-site studies and maintain the Master Schedule.
Conduct audits (facility, process-based) and review Standard Operating Procedures (SOPs).
Provide regulatory training and host/liaise with regulatory agencies during audits.
Support supplier qualifications, track deviations/audit findings, and lead CAPA/process improvement projects.
Assist with CSV activities, serve as backup archivist, and handle other assigned tasks.
Qualifications for the QA Auditor include:
Bachelor's degree in life sciences, animal science, or similar field is required at minimum.
5+ years of QA experience in preclinical GLP studies preferred.
Strong communication skills and understanding of protocols, GLPs, and laboratory operations.
RQAP certification (preferred).
Compensation for the QA Auditor includes:
Salary Range: approximately $65,000 - $85,000 annually, commensurate with experience
Comprehensive Benefits: Medical, Dental, Vision, 401k, PTO, Paid Holidays, Sick leave as required by law
This job is open for applications on 5/2/2025. Applications for this role will be accepted at least 30 days from the posting date.
Senior qa auditor, quality assurance auditor, qa, glp, good laboratory practices, preclinical, life sciences, in vivo, in vitro, animal studies, cqa, rqap, method validation, regulatory, compliance, audit, inspection, fda, food and drug administration, iacuc, veterinary medicine, vaccine, therapeutics, biotherapeutics, bioservices
#LI-CP1
#LI-ONSITE
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.