Quality Assurance Auditor

Actalent is seeking a Quality Assurance Auditor to develop and maintain a robust internal compliance program in an FDA-regulated, cGMP manufacturing environment. This role involves planning and conducting audits, managing supplier and vendor qualification programs, and supporting regulatory inspection readiness.

Responsibilities

• Plan, schedule, and execute internal and external audits to assess compliance with applicable regulations and company quality standards.
• Audit external suppliers, including contract manufacturing organizations (CMOs), and maintain the vendor qualification program, including the Approved Vendor List within Qualityze.
• Manage external vendors responsible for conducting international audits and ensure their activities align with company quality and compliance expectations.
• Oversee the supplier corrective action request (SCAR) program and ensure timely and effective resolution of supplier-related quality issues.
• Manage and maintain all documents related to audits, vendors, and suppliers within the Quality Management System (QMS), including Qualityze.
• Assess audit findings, determine the level of risk, and follow up on corrective and preventive actions to ensure both short-term corrections and long-term preventive measures are implemented.
• Develop and implement performance tracking systems and reporting tools to monitor departmental compliance and audit performance.
• Prioritize workload to ensure that audits, reports, and follow-up activities are completed accurately and on time.
• Support the implementation of the Corrective and Preventive Action (CAPA) program where necessary, including investigations and follow-up activities.
• Train and assist internal departments to understand and comply with quality and compliance expectations, policies, and procedures.
• Assess the internal audit process by identifying and prioritizing areas of risk for non-compliance and assist in developing or executing processes and policies to reduce that risk.
• Support training and readiness activities for regulatory inspections, including preparation of documentation and coordination with relevant departments.
• Provide ongoing support to other Quality Assurance team members to meet departmental and company quality objectives.
• Report audit metrics and trends to Quality Assurance and departmental leadership to support data-driven decision-making.
• Communicate effectively with all levels of the organization and across departments, fostering collaboration and a strong team environment.
• Understand the roles and responsibilities of contract manufacturing organizations and provide Quality Assurance support for product development, investigations, and CAPAs as required.
• Utilize and remain familiar with Quality Assurance functions in SAP to support quality and compliance activities.
• Perform other duties as assigned to support Quality Assurance and overall company objectives.

Requirements

• Minimum of 5 years of Quality Assurance auditing experience in a cGMP environment.
• Minimum of 5 years of external vendor and supplier compliance auditing experience within an FDA-regulated industry.
• Proven experience conducting both internal and external audits.
• Experience working in manufacturing environments, including exposure to clean rooms.
• Strong understanding of cGMP principles and FDA-regulated industry practices.
• Proficiency with computer software applications, including the Microsoft Office Suite.
• Ability to stand, walk, push, and pull in a variety of environments, including manufacturing areas and clean rooms.
• Ability to wear all required Personal Protective Equipment (PPE) appropriate to the auditing environment.
• Ability to travel approximately 20–30% for domestic audits, sometimes with limited notice, and flexibility for potential international travel as needed.
• Strong adaptability and flexibility in a dynamic quality and compliance environment.
• Demonstrated initiative and a proactive approach to identifying and resolving quality and compliance issues.
• Excellent interpersonal skills with the ability to build and maintain strong relationships with operations teams and suppliers.
• B.A. or B.S. degree in a science or technical field.

Skills

• Knowledge of FDA regulations 21 CFR Parts 210, 211, and 507, as well as Dietary Supplement Regulations 21 CFR 111, is preferred.
• ASQ Certified Quality Auditor (CQA) certification is preferred.
• Experience managing supplier corrective action request (SCAR) programs.
• Experience supporting and implementing CAPA programs, including investigations and preventive actions.
• Familiarity with Quality Management Systems, particularly Qualityze, for managing audits, vendors, and supplier documentation.
• Experience with QA-related functions and processes in SAP.
• Strong communication skills, both written and verbal, with the ability to present audit findings and metrics clearly to leadership.
• Ability to develop and implement performance tracking systems and compliance reporting.
• Commitment to values such as honesty, integrity, commitment, and responsibility.

Schedule

This is a full-time, first-shift position with typical hours of Monday through Friday, 8:30 a.m. to 5:00 p.m.

Pay

The pay range for this position is $70,000.00 - $95,000.00 per year.

Benefits

• Medical insurance
• Vision insurance
• Dental insurance
• 401(k)
• Disability insurance
• Tuition assistance
• Child care support
• Discretionary bonus potential
• Relocation assistance

Work Environment

This role operates in a mixed office and manufacturing environment, including time spent in clean rooms and on the production floor, where wearing appropriate Personal Prote Equipment (PPE) is required. The company fosters a strong, values-driven culture that emphasizes honesty, integrity, commitment, and responsibility, and offers opportunities to work cross-functionally within the Quality Assurance function.