Quality Assurance Specialist
Marin Metro Area, California
Great Opportunity for candidates wanting to grow and establish a career in QA.
- Assist in the evaluation of compliance of nonclinical and bioanalytical studies conducted by the Company to FDA Good Laboratory Practices (GLP) regulations and any other applicable GLP international regulations and guidelines, and to corporate policies and standard operating procedures (SOPs).
- Perform domestic GLP audits to assess the company's compliance to FDA government regulations, scientific protocols and internal SOPs as they relate to GLP Quality Assurance and regulatory GLP compliance.
- In addition, assist in performing internal systems audits and reviews.
- Communicate findings to the appropriate scientists and management.
- Assist with GLP regulatory compliance training and with special GLP Compliance systems and corporate projects.
- Experience in Biology, Chemistry, or applicable Life Science with a minimum of 0-2 years related experience in GLP and/or GxP programs. Requires a BS degree in scientific discipline. Additional experience in GCP and/or GMP QA, a plus.
- Basic experience in auditing or relevant laboratory/facility setting experience.
- Possess good interpersonal, organizational and verbal/written communication skills.
- Minimum/Required: Bachelor s (BA/BS) in a Life Science or closely related field of study