|Lancaster, South Carolina - United States
$50,000.00 - $75,000.00 - US Dollars - Yearly
WHY IS THIS A GREAT OPPORTUNITY?
We are looking for an External Auditor that reports to the Senior QA Manager. This role is responsible for developing and maintaining a strong program ensuring compliance to applicable regulations. The EA is primarily responsible for external auditing but also required to support internal audits as needed. The EA must prioritize schedule of audits and have oversight for corrective actions to the findings identified. Domestic and international travel is a necessity for this position.
Roles and Responsibilities:
- Manage audit planning, scheduling, and execute external audits to support the business
- Develop and implement vendors and suppliers scorecards and review with management annually
- Coordinate activities with other auditors and QA Personnel for efficiency.
- 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.
- Develop and implement a performance tracking system and reporting of departmental compliance.
- 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.
- Assessing the Internal audit process by identifying and prioritizing areas of the business where there is a risk of non-compliance and assist in the development and/ or execute processes or policies to reduce that risk.
- Support training and readiness for regulatory inspections.
- Provide support to the South Carolina and Maryland Quality Assurance team.
- Report audit metrics to Quality Assurance and department management.
- Performance of other duties may be required for meeting compliance requirements.
- Regular Attendance is required.
- Communicate effectively with other departments within the organization and function within a team environment.
- Perform other assigned duties as may be required in meeting company objective
- Knowledge of the Regulations 21 CFR 507 as well as the Dietary Supplement Regulations 21 CFR 111.
- Must have a minimum of 5 years of experience in Quality Assurance including Supplier Quality Management.
- ASQ Certified Auditor (CQA) Certification is preferred.
- Experience auditing for compliance.
- Strong knowledge of GMP manufacturing regulations.
- Must be proficient in MS office suite.
- Must be able to effectively communicate with other departments and function within a team environment.
- Must be able to stand or walk for long periods, as well as be able to walk outdoors on potentially uneven surfaces to assess facility exteriors.
- Must be able to travel for audits as needed by the company
- B.A or B.S in Science or Technical Field preferred, but not required.
University - Bachelor's Degree/3-4 Year Degree