Job Description

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