Careers at Masis Staffing Solutions

Quality Assurance Auditor | Pharmaceutical cGMP
30-45 minutes of Charlotte, NC
$80k-$100k + discretionary bonus potential up to 12% of YTD earnings
US Citizens or Green Card Holders only | No C2C
M-F 8:30am – 5:00pm

Join an industry-leading health and wellness manufacturer dedicated to improving lives through science, innovation, and uncompromising quality. With a strong reputation for excellence, the company develops trusted products backed by research and produced to the highest standards of quality and compliance.

The Quality Assurance Auditor | Pharmaceutical cGMP reports to the Supplier Quality and Compliance Manager. 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.

Must-Haves:

• 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.
• Experience with 21 CFR Parts 210, 211 and 21 CFR 111
• ASQ Certified Auditor (CQA) Certification is preferred.
• Must be proficient in Computer Software applications including MS office suite.
• Must be able to travel 20 – 30% for domestic audits, (International travel may be needed per quality management).

What You'll Do:

• Plan, schedule, and conduct internal and external audits to ensure regulatory and quality compliance.
• Audit suppliers and contract manufacturers (CMOs) and maintain vendor qualification programs.
• Manage supplier corrective actions (SCARs) and verify effective CAPA implementation.
• Assess audit findings, determine risk levels, and drive corrective and preventive actions.
• Maintain audit, supplier, and compliance documentation within the Quality Management System (QMS).
• Monitor and report audit and compliance metrics to management.
• Train and support cross-functional teams on quality and compliance requirements.
• Identify compliance risks and support process improvements to mitigate risk.
• Support regulatory inspection readiness and ongoing compliance initiatives.
• Utilize SAP and electronic quality systems to support Quality Assurance activities.

Preferred:

•  ASQ Certified Quality Auditor (CQA) preferred.
•  SAP and Quality Management System experience

 Outstanding Benefits & Relocation Package! 

• 45 Days of Fully Furnished Temporary Housing
• $5,000 Relocation Stipend
• Paid Area Exploration Visits
• Weekly Pay
• Christmas Eve–New Year's Shutdown
• Up to $5,000 Annual Tuition Reimbursement
• Gym/Fitness Reimbursement
• Company-Paid Life Insurance
• Company-Paid Short-Term Disability
• Employee Assistance Program (EAP)
• Annual HSA Contribution
• Daycare & Private School Tuition Assistance

A company that truly invests in its employees and their families! 

#MPGAll

Masis Staffing is committed to providing a workplace free of discrimination, harassment, and retaliation. We are an equal opportunity employer. Applicants, employees, and former employees are protected from employment discrimination based on race, color, religion, sex (including pregnancy, sexual orientation or transgender status), national origin, age (40 or older), veteran status, disability and genetic information (including family medical history).