What are the responsibilities and job description for the Quality Assurance Auditor | cGMP | FDA position at Masis Professional Group?
π Quality Assurance Auditor | cGMP | FDA
π 30-45 minutes of Charlotte, NC
π° $85k-$100k discretionary bonus potential up to 12% of YTD earnings
π¨ US Citizens or Green Card Holders only | No C2C
π°οΈ M-F 8:30am β 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
.
Employees enjoy a collaborative, values-driven culture that emphasizes integrity, continuous improvement, professional growth, and making a meaningful impact every day. If you're looking to join a mission-focused organization where quality matters and people are valued, you'll feel right at home her
e!
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 to applicable regulations. The QAA is required to perform internal and external audits, prioritize audit schedules and corrective actions to the findings identifi
ed.
β
Must-Ha
- ves: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 indus
- try.Experience with 21 CFR Parts 210, 211 and 21 CFR
- 111ASQ Certified Auditor (CQA) Certification is prefer
- red.Must be proficient in Computer Software applications including MS office su
- ite.Must be able to travel 20 β 30% for domestic audits, (International travel may be needed per quality manageme
nt).
β‘οΈ What You'l
- l Do:Plan, schedule, and conduct internal and external audits to ensure regulatory and quality compli
- ance.Audit suppliers and contract manufacturers (CMOs) and maintain vendor qualification prog
- rams.Manage supplier corrective actions (SCARs) and verify effective CAPA implementa
- tion.Assess audit findings, determine risk levels, and drive corrective and preventive act
- ions.Maintain audit, supplier, and compliance documentation within the Quality Management System (
- QMS).Monitor and report audit and compliance metrics to manage
- ment.Train and support cross-functional teams on quality and compliance requirem
- ents.Identify compliance risks and support process improvements to mitigate
- risk.Support regulatory inspection readiness and ongoing compliance initiat
- ives.Utilize SAP and electronic quality systems to support Quality Assurance activi
ties.Prefe
rred: β ASQ Certified Quality Auditor (CQA) prefe
rred. β SAP and Quality Management System exper
ience
β¨ Outstanding Benefits & Relocation Pack
- age! β¨
45 Days of Fully Furnished Temporary - Housing$5,000 Relocation
- StipendPaid Area Exploration
- VisitsWee
- kly PayChristmas EveβNew Year's S
- hutdownUp to $5,000 Annual Tuition Reimbu
- rsementGym/Fitness Reimbu
- rsementCompany-Paid Life In
- suranceCompany-Paid Short-Term Dis
- abilityEmployee Assistance Progra
- m (EAP)Annual HSA Contr
- ibutionDaycare & Private School Tuition Ass
istance
β A company that truly invests in its employees and their fam
Salary : $90,000 - $100,000