Quality Assurance Auditor (FDA-regulated)

Element Staffing Services; Lancaster (SC); On-site; USD 85,000 - 110,000; Full time

Job summary

Element Staffing Services is seeking a Quality Assurance Auditor in the Lancaster, SC area to lead internal and external audits, enforce cGMP compliance, and manage supplier qualification programs. The role reports to QA leadership and requires ensuring timely audit execution and CAPA effectiveness.

Ideal candidates have 5+ years of QA auditing in FDA-regulated environments, familiarity with 21 CFR parts, and ASQ CQA preferred. Travel up to 30% may be necessary to support audits and inspections.

Qualifications

• Minimum 5 years of QA auditing in cGMP with 5 years external vendor/supplier auditing in FDA-regulated industry.
• Knowledge of 21 CFR Part 210, 211, 507 and DS 21 CFR 111.
• ASQ Certified Auditor (CQA) preferred.
• Proficient with MS Office and document management systems.
• Willingness to travel 20–30% for domestic audits; some international travel may be required.

Responsibilities

• Manage and execute internal and external audits for compliance.
• Oversee vendor qualification programs and Approved Vendor List.
• Lead CAPA/Corrective Actions and track closure.
• Prepare audit reports and present metrics to QA leadership.
• Assist in regulatory inspection readiness and training.
• Review CMO batch records and support batch release as needed.
• Maintain QA documentation in the QMS and ensure process compliance.

Skills

QA auditing

Regulatory knowledge

Vendor management

CAPA handling

Documentation

Education

Bachelor's degree in Science/Technical field

Tools

SAP

MS Office

Job description

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.
• 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.