Quality Assurance Auditor - GMP
Actalent, Lancaster, SC, United States
Overview
The Quality Assurance Auditor reports to the Supplier Quality and Compliance Manager. This role is responsible for developing and maintaining a strong Internal Compliance program ensuring compliance with applicable regulations. The QAA is required to perform internal and external audits, prioritize audit schedules, and address corrective actions to identified findings.
Roles and Responsibilities
Manage audit planning, scheduling, and execution of internal and external audits for Nutramax Laboratories to assess compliance with 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 to ensure they address both short‑term corrections and preventive actions.
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 processes by identifying and prioritizing areas of the business with risk of non‑compliance and assist in developing or executing 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 function within a team environment.
Understand the roles and responsibilities of the Contract Manufacturing Organizations and provide QA support for product development, investigations, and CAPAs as required.
Familiar with QA functions in SAP.
Perform other assigned duties as may be required to meet QA and company objectives.
Skills
Quality assurance
GMP
CAPA
FDA
ASQ certified
Education and Experience
B.A. or B.S. in Science or Technical field required.
Experience Level
Intermediate Level
Job Type & Location
Permanent position based out of Lancaster, SC.
Pay and Benefits
The pay range for this position is $70,000.00 – $90,000.00 per year.
Medical insurance
Vision insurance
Dental insurance
401(k)
Disability insurance
Tuition assistance
Child care support
Workplace Type
Fully onsite position in Lancaster, SC.
Application Deadline
This position is anticipated to close on Apr 29, 2026.
Diversity, Equity & Inclusion
Hiring diverse talent
Maintaining an inclusive environment through persistent self‑reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
Equal Opportunity Employment
Actalent is an equal opportunity employer.
#J-18808-Ljbffr
The Quality Assurance Auditor reports to the Supplier Quality and Compliance Manager. This role is responsible for developing and maintaining a strong Internal Compliance program ensuring compliance with applicable regulations. The QAA is required to perform internal and external audits, prioritize audit schedules, and address corrective actions to identified findings.
Roles and Responsibilities
Manage audit planning, scheduling, and execution of internal and external audits for Nutramax Laboratories to assess compliance with 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 to ensure they address both short‑term corrections and preventive actions.
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 processes by identifying and prioritizing areas of the business with risk of non‑compliance and assist in developing or executing 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 function within a team environment.
Understand the roles and responsibilities of the Contract Manufacturing Organizations and provide QA support for product development, investigations, and CAPAs as required.
Familiar with QA functions in SAP.
Perform other assigned duties as may be required to meet QA and company objectives.
Skills
Quality assurance
GMP
CAPA
FDA
ASQ certified
Education and Experience
B.A. or B.S. in Science or Technical field required.
Experience Level
Intermediate Level
Job Type & Location
Permanent position based out of Lancaster, SC.
Pay and Benefits
The pay range for this position is $70,000.00 – $90,000.00 per year.
Medical insurance
Vision insurance
Dental insurance
401(k)
Disability insurance
Tuition assistance
Child care support
Workplace Type
Fully onsite position in Lancaster, SC.
Application Deadline
This position is anticipated to close on Apr 29, 2026.
Diversity, Equity & Inclusion
Hiring diverse talent
Maintaining an inclusive environment through persistent self‑reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
Equal Opportunity Employment
Actalent is an equal opportunity employer.
#J-18808-Ljbffr