Responsibilities
- The Quality Assurance Auditor is responsible for developing, maintaining and ensuring compliance in a CGMP environment.
- Manage audit planning, scheduling, and execute internal audits in facilities to assess compliance to the regulations.
- Determine the level of risk of findings identified and follow up on corrective actions ensuring they address the short-term correction as well as the preventive action of the finding.
- Prioritize work to ensure that audits and reports are completed in a timely manner. Support implementation of CAPA program where necessary. Assist internal departments so that they are able to understand and comply with Quality and Compliance expectations.
- $70K-$90K. Some relocation provided, regional candidates preferred.
Requirements
- The Quality Assurance Auditor will have a Bachelor’s degree and 5+ years of experience in Quality Assurance including supplier quality.
- Knowledge of the Regulations 21 CFR 507 as well as 21 CFR 111.
- ASQ Certified Auditor (CQA) Certification is preferred.
- Strong knowledge of GMP manufacturing regulations.
- Must be legally eligible to work in the U.S. and have a stable work history. Sponsorship is not available.