Quality Assurance Auditor I

Alliance Pharmaposted 3 months ago

Full-time • Entry Level

Malvern, PA

Chemical Manufacturing

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About the position

Resolian is a Contract Research Organization (CRO) specializing in Drug Metabolism and Pharmacokinetic (DMPK) and bioanalytical services for both small and large molecules. At Resolian, we work to bring together and develop exceptional employees and colleagues who share our passion for generating significant contributions to the world. We take pride in our work and our employees. Resolian strives to help you and your family by offering a comprehensive benefits package. Our total rewards are designed to recognize outstanding performance and meet the diversified needs of all our colleagues - at every stage of their professional and personal lives. We continually strive to maintain the highest standards of professional ethics, scientific excellence, and regulatory compliance. We work to build trusted partnerships with each of our employees.

Responsibilities

Learn and review documents against regulatory requirements; GLP, GCP, EPA, OECD, 21CFR Part 11
Verify lab tasks are performed in accordance with Good Documentation Practices (GDP)
Review laboratory documents and notebooks (e.g., plans, experiment/sample runs, chromatograms, instrument logs, etc.) for compliance to SOPs and applicable regulations
Learn to identify non-compliance and deviations
Review sample analysis documents for compliance to validated/qualified methods
Verify run pass/fail
Follow applicable SOPs and procedural documents
Review data result files, validation data files, and reports
Learn to prepare and submit study data to archives
Escalate data integrity and non-compliance issues to Management
Enforce lab safety SOPs and requirements
Review system audit trails
Other tasks as assigned