Quality Assurance Auditor (FDA-regulated)

Job Title: Quality Assurance Auditor (FDA-regulated)

Job Description: Element Staffing is recruiting for Quality Assurance Auditor for a client in the Lancaster SC area. Please see below for requirements!

Summary of the Position

The Quality Assurance Auditor reports to the Director of Quality. This role is responsible for developing and maintaining a strong Internal Compliance program ensuring compliance to applicable regulations. The QAA is required to perform internal and external audits, prioritize audit schedules and corrective actions to the findings identified.

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.
• 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.
• Review and Release CMO batch records and assist with in house batch release as needed.
• Familiar with QA functions in SAP.
• Perform other assigned duties as may be required in meeting Quality Assurance and company objectives.

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 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).

Education and Experience: B.A. or B.S. in Science or Technical field required.