Quality Assurance Auditor I/II
Essential Responsibilities
- Able to perform Quality Assurance (QA) audits, inspections (internal/external) and monitoring procedures against standard operating procedures, methods, protocols/plans, guidances, and/or regulations, as applicable
- Issue QA statements for reports as needed
- Assist in hosting regulatory inspections by acting as scribe and/or reviewing documents and identifying and calling operational staff to answer questions as required
- Assist in writing and reviewing QA standard operating procedures
- Positively impacts the company through successful contributions, active participation and identification of compliance gaps
- Obtain and maintain professional and technical knowledge by attending educational workshops; review professional publications; establish personal networks
- Assist in document management activities
- Perform duties with minimal QA Management oversite
- Other duties as needed
Minimum Acceptable Qualifications
Education/Experience:
- Bachelor's degree with minimum of 3 years of experience in the field or in a related field
- Internal and/or external GxP auditing experience
Skills:
- Ability to work in fast paced environment where multiple projects are in process and must be completed in a timely manner
- Excellent oral and written communication skills
