What are the responsibilities and job description for the Quality Assurance Auditor (GMP/GLP) – Life Sciences/Pharma/Biotech position at Azaaki LLC?
Title: Quality Assurance Auditor (GMP/GLP) – Life Sciences/Pharma/Biotech
Location: Wayne, PA 19087 (Onsite)
Pay Rate: $30–$33/hr
Duration: 1 Year Contract
Schedule: Monday–Friday, 9:00 AM–5:00 PM
#Azaaki-NonIT
Job Summary
The Quality Assurance Auditor will support routine QA operations by auditing basic records, reports, and processes to ensure compliance with GMP/GLP regulations, international standards, and corporate quality policies. This role is ideal for early-career candidates with strong attention to detail and hands-on laboratory experience in a regulated (GMP/GLP) environment.
Key Responsibilities
Audit & Compliance
- Perform audits of records, reports, data, and routine processes to ensure compliance with federal, state, and local regulations and corporate SOPs.
- Conduct data integrity audits ensuring ALCOA principles (Attributable, Legible, Contemporaneous, Original, Accurate).
- Review SOPs, protocols, batch records, and reports for completeness, accuracy, and regulatory alignment.
- Identify, document, and report deviations from SOPs, protocols, and specifications.
- Maintain accurate, signed documentation of all audits and inspections.
Quality Support & Documentation
- Participate in client/sponsor audits and regulatory inspections.
- Support CAPA activities by assisting in investigation and follow-up of quality or regulatory findings.
- Conduct inspections of subcontractors, vendors, suppliers, and incoming materials for compliance with specifications.
- Assist in QA training, audit scheduling, and tracking activities.
- Participate in manufacturing line clearances and verify room readiness before production.
- Support Regulatory Affairs and Compliance project assignments as needed.
Lab Documentation Review
- Review GMP documentation generated during laboratory testing.
- Copy edit and verify accuracy, data consistency, and adherence to quality standards.
Qualifications
Education
- Bachelor’s degree in Biology, Life Sciences, or a related scientific discipline required.
Experience
- 1–2 years of experience in Quality Assurance, GMP, or GLP laboratory settings.
- GMP laboratory experience strongly preferred; GLP experience acceptable.
Technical Knowledge
- Understanding of FDA, GLP, GMP, and/or ISO quality standards.
- Proficiency in Microsoft Office (Word, Excel, Access).
Skills
- Highly detail-oriented with strong analytical and critical-thinking abilities.
- Excellent written and verbal communication skills.
- Ability to review, interpret, and audit scientific documentation with precision.
Job Type: Contract
Pay: $30.00 - $33.00 per hour
Work Location: In person
Salary : $30 - $33
