Sr. Quality Assurance Specialist

Position Summary

Reporting directly to the Sr. Manager, of Quality Assurance, the position is responsible for supporting quality systems covering pre-clinical studies (GLP) and laboratory clinical (GCLP) testing activities.

Position Requirements

• Provide local oversight (i.e., tertiary review) and elevate all serious issues to the Director of Quality Assurance.
• Represent QA on local project and test site meetings.
• Assure regulatory requirements are met by auditing the protocol, raw data, data summary tables, draft and final reports associated with nonclinical studies or bioanalytical sample analysis protocols.
• Excellent understanding of GLP and GCLP for FDA and applicable international regulations.
• Audit IQ, OQ, PQ, of, software, computerized systems, or laboratory equipment validation reports.
• Authors and/or reviews Standard Operating Procedures (SOPs).
• Identify regulatory compliance issues and provide regulatory support to departments.
• Plan, conduct and report inspections of the internal bioanalytical laboratory.
• Plan, conduct and report audits of external Laboratory Clinical or Non-clinical Laboratory Study and bioanalytical laboratories to assess compliance with regulatory standards.
• Ability to travel domestically and internationally – approximately 10-15%.
• Provide QA support for risk assessment and remediation, and identification and investigation/CAPA of deviations.
• It is imperative that Amador Bioscience employees embody our core values by working collaboratively, building strong relationships and using clear communication to meet shared objectives.
• Assure QA department inspection reports and any other supporting documentation or required records are appropriately retained, processed and archived, as appropriate.

Experience and Qualifications

• Must have excellent attention to detail and time management skills as well as the ability to manage multiple priorities with aggressive timelines and changing priorities.
• Excellent verbal or written communication skills with the ability to interact with all levels of employees.
• Bachelor’s degree in a scientific discipline (i.e., Biology, Chemistry, etc.) including a minimum of 4 years’ QA experience auditing in a GLP or GCLP environments, or QC of bioanalytical data. Experience auditing in a GLP bioanalytical laboratory is preferred.

Preferred Qualifications:

• RQAP-GLP, or other applicable certification or registration.
• Experience supporting GCP clinical sample analysis audits.
• Advanced emotional intelligence and career savvy required to form resonant relationships with internal and external stakeholders.
• Experience conducting assays in a bioanalytical laboratory.
• Experience in conducting detailed external and internal audits.