Quality Assurance Auditor Jobs

My client is looking for a QA Auditor to join their team of highly experienced scientists and professionals that deliver tailored services for supporting new medicine breakthroughs with best-in-class bioanalytical services.

Responsibilities:

• Obtain and maintain professional and technical knowledge by attending educational workshops; review professional publications; establish personal networks
• Issue QA statements for reports as needed
• Performs Quality Assurance (QA) audits, inspections (internal/external), and monitoring procedures against standard operating procedures, methods, protocols/plans, guidance's, and/or regulations, as applicable
• Positively impacts the company through successful contributions, active participation and identification of compliance gaps
• Perform duties with minimal QA Management oversight
• Assist in document management activities
• Assist in writing and reviewing QA standard operating procedures
• Assist in hosting regulatory inspections by acting as scribe and/or reviewing documents and identifying and calling operational staff to answer questions as required

Education:

• 2+ years’ experience working in a laboratory/bench role/operations
• 3+ years’ experience in GLP/GCLP/GMP quality assurance (QA)
• Bachelor’s degree in biology, chemistry, biochemistry, medical technology, or other scientific discipline
• Experience working in biotech, pharmaceutical, CRO/CMO or similar organization

Skills:

• Ability to work in fast-paced environment where multiple projects are in process and must be completed in a timely manner
• Internal and/or external GxP auditing experience
• Ability to deal effectively with a diversity of individuals at all organizational levels
• Proficiency in Microsoft Office (Word, Excel, Outlook, etc.)