Senior Quality Assurance Auditor
Celcuity
6 months ago
Remote
United States
Operations
Responsibilities:
- Conduct vendor, investigator site, and internal audits according to applicable GxP requirements.
- Prepare detailed, high-quality audit reports and facilitate responses to audit observations.
- Support the vendor management program by performing initial audits of vendors.
- Manage the audit process through the quality management system.
- Lead or participate in strategic initiatives to continuously improve the Quality Management System (QMS), audit processes, and overall compliance to global standards.
- Provide guidance and training on GxP requirements to functional area personnel.
- Provide guidance and support during inspections and assist in developing responses to agency observations.
- Provide audit metrics to Executive Management.
- Working knowledge of regulatory requirements (FDA, EU) and related standards (GxP, CAP, CLIA).
- Other duties as assigned.
Qualifications:
- Bachelor’s degree in health or life sciences; or relevant experience.
- 10+ years of experience in auditing and quality management systems in pharmaceutical, biotechnology, or medical device industries in a GxP regulated environment.
- Relevant professional certifications such as ASQ Certified Quality Auditor (CQA) or a Lead Auditor certification (highly preferred).
- Excellent written and verbal communication skills; ability to influence and build credibility at all levels.
- Strong interpersonal skills across various levels and functions.
- Attention to detail and ability to manage multiple processes and documentation requirements.
- Analytical and problem-solving skills to evaluate complex compliance issues.
- Strong technical/analytical skills; advanced MS Office (Word, Excel, PowerPoint).
- Experience with Veeva Quality Vault software (required).
- Ability to work independently or in a team as required.
- Outstanding organizational skills; ability to prioritize.
- Sound decision-making; critical thinking in a fast-paced environment.
- Continuous improvement mindset.
- Flexible and willing to learn; adapt to business/site needs.
- Positive, approachable, professional attitude.
Benefits:
- Annual performance incentive bonus; new hire equity package.
- Medical, dental, vision insurance, 401(k) match, PTO, and paid holidays.
- Conduct vendor, investigator site, and internal audits according to applicable GxP requirements.
- Prepare detailed, high-quality audit reports and facilitate responses to audit observations.
- Support the vendor management program by performing initial audits of vendors.
- Manage the audit process through the quality management system.
- Lead or participate in strategic initiatives to continuously improve the Quality Management System (QMS), audit processes, and overall compliance to global standards.
- Provide guidance and training on GxP requirements to functional area personnel.
- Provide guidance and support during inspections and assist in developing responses to agency observations.
- Provide audit metrics to Executive Management.
- Working knowledge of regulatory requirements (FDA, EU) and related standards (GxP, CAP, CLIA).
- Other duties as assigned.
Qualifications:
- Bachelor’s degree in health or life sciences; or relevant experience.
- 10+ years of experience in auditing and quality management systems in pharmaceutical, biotechnology, or medical device industries in a GxP regulated environment.
- Relevant professional certifications such as ASQ Certified Quality Auditor (CQA) or a Lead Auditor certification (highly preferred).
- Excellent written and verbal communication skills; ability to influence and build credibility at all levels.
- Strong interpersonal skills across various levels and functions.
- Attention to detail and ability to manage multiple processes and documentation requirements.
- Analytical and problem-solving skills to evaluate complex compliance issues.
- Strong technical/analytical skills; advanced MS Office (Word, Excel, PowerPoint).
- Experience with Veeva Quality Vault software (required).
- Ability to work independently or in a team as required.
- Outstanding organizational skills; ability to prioritize.
- Sound decision-making; critical thinking in a fast-paced environment.
- Continuous improvement mindset.
- Flexible and willing to learn; adapt to business/site needs.
- Positive, approachable, professional attitude.
Benefits:
- Annual performance incentive bonus; new hire equity package.
- Medical, dental, vision insurance, 401(k) match, PTO, and paid holidays.