Sr. Quality Assurance Specialist (GLP)

Amador Bioscience (AmadorBio) is a Translational & Clinical Pharmacology CRO providing global-standard services in quantitative clinical pharmacology, GLP/GCLP bioanalysis, clinical research, and regulatory filing to leading biopharmaceutical companies. Our clients include multinational pharmaceuticals and mid- and small-size biotech companies.

Reporting to the Sr. Quality Assurance Manager, this role is responsible for administering quality systems supporting compliant nonclinical laboratory study Good Laboratory Practice (GLP) and or phases thereof and testing activities producing primary or secondary endpoints of clinical studies Good Clinical Laboratory Practice (GCLP). Assure Test Site Management (TSM) that facilities, equipment, personnel, methods, practices, records, and controls are in conformance of regulations.

Key Responsibilities

• Facilitate company compliance of GLP and GCLP and GCPs for FDA and applicable international regulations.
• Contribute to the company Master Schedule.
• Writing and updating QA Standard Operating Procedures (SOP’s), QA Files, and QA Audit Log.
• Assure QA department inspection reports and any other supporting documentation or required records are processed and archived, as appropriate.
• Monitor regulatory landscape and interpret regulatory requirements for application to business processes and procedures, and corporate Risk Register.
• Review Standard Operating Procedures (SOPs) and Statistical Analysis Plans (SAP).
• Assure GLP protocol requirements are met by auditing phase specific raw data, data summary tables, draft and final phase reports associated with nonclinical studies or bioanalytical sample analysis protocols to evaluate regulatory compliance.
• Provide basic GLP and GCLP training as needed.
• Plan, conduct and report inspections of the internal facilities to TSM.
• Plan, conduct and report audits of external vendors to assess compliance with regulations, industry standards, and best practices.
• Identify regulatory compliance issues and provide regulatory support to departments.
• Contribute to the monthly status report of the company's compliance with GLP and GCLP regulations including problems and corrective action.
• Represent QA in test site and project specific meetings.
• Establish and maintain a state of inspection readiness including test site specific folder.
• Host client and regulatory inspections including preparing responses of findings thereof.
• Perform all other related duties as assigned and relevant to job title.

Qualifications and Education Requirements

• Bachelor’s or Master’s degree in biology, immunology, chemistry, pharmacology, or other related scientific fields required;
• A minimum of 5 years relevant experience in Quality Assurance within a GLP-centered research or pharmaceutical industry setting.
• The ability to lead Quality audits.
• Knowledge of regulated bioanalysis. GCP/GCLP experience necessary.
• Goal-oriented, quality-conscientious, and client-focused.