Quality Assurance Auditor

Roles and Responsibilities

- Manage audit planning, scheduling, and execute internal and external audits for Nutramax Laboratories to assess compliance to the regulations.

- Audit external suppliers (CMO’s) and maintain the vendor qualification program including the Approved Vendor List in Qualityze

- Manage external vendor(s) responsible for international audits

- Manage the Nutramax supplier corrective action request program (SCAR).

- Manage all documents relating to audits, vendors, and suppliers in a QMS (Qualityze)

- 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.

- Train and assist internal departments to understand and comply with Quality and Compliance expectations.

- Assess internal audit process by identifying and prioritizing areas of the business where there is a risk of non-compliance and assist in development and/or execute processes or policies to reduce that risk.

- Support training and readiness for regulatory inspections.

- Provide support to other Quality Assurance team members.

- Report audit metrics to Quality Assurance and department management.

- Communicate effectively with all levels of the organization and departments within the organization and function within a team environment.

- Understand the roles and responsibilities of the Contract Manufacturing Organizations and provide Quality Assurance support for product development, investigations, and CAPAs as required.

- Familiar with QA functions in SAP.

- Perform other assigned duties as may be required in meeting Quality Assurance and company objectives.

Requirements

Minimum Requirements

- Must have a minimum of 5 years of Quality Assurance auditing experience in cGMP environment with a minimum of 5 years of external vendor/ supplier compliance auditing experience within an FDA regulated industry.

- Knowledge of the Regulations 21CFR Part(s) 210, 211, 507 as well as the Dietary Supplement Regulations 21 CFR 111 is required.

- ASQ Certified Auditor (CQA) Certification is preferred.

- Must be proficient in Computer Software applications including MS office suite.

- Must be able to stand, walk, push, and pull in a variety of environments including a Manufacturing and clean rooms.

- Must have the ability to wear all required Personal Protective Equipment (PPE) based on the auditing environment.

- Must be able to travel 20 – 30% for domestic audits, (International travel may be needed per quality management).

Job Type: Full-time

Pay: $75,000.00 - $100,000.00 per year

Benefits:

- 401(k)

- Health insurance

- Relocation assistance

- Vision insurance

Work Location: In person