Nutramaxlabs Laboratories
  • Lancaster, SC, USA
  • Full Time

Summary of the Position: The Quality Assurance Auditor reports to the Sr. Supplier Quality Engineer.  This role is responsible for developing and maintaining a strong Internal Compliance program ensuring compliance to applicable regulations. The QAA is also required to support external audits, prioritize audit schedules and corrective actions to the findings identified. 

Roles and Responsibilities:

  • Manage audit planning, scheduling, and execute internal audits in South Carolina and Maryland Facilities to assess compliance to the regulations.
  • Audit external suppliers and support the efforts of Supplier Quality Engineer with the vendor qualification program.
  • 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 the South Carolina and Maryland Quality Assurance team.
  • 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.
  • Perform other assigned duties as may be required in meeting Quality Assurance and company objectives

 

 

Minimum Requirements:  

  • Must have a minimum of 5 years of Quality Assurance auditing experience in GMP environment with a minimum of 3 years of external vendor/supplier compliance auditing experience within a FDA regulated industry.  Prior experience in pharmaceutical, food, or medical device industry a plus.
  • Knowledge of the Regulations 21 CFR 507 as well as the Dietary Supplement Regulations 21 CFR 111 a plus.
  • ASQ Certified Auditor (CQA) Certification is preferred.
  • Must be proficient in 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 audits including international travel.

 

Education and Experience:  B.A or B.S in Science or Technical Field preferred, but not required.

Nutramaxlabs Laboratories
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