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Quality Assurance Auditor (cGMP)

Location: Charlotte, NC
Job Type: Direct Hire
Salary: $50,000.00 - $60,000.00
Degree: Bachelor;
Date: 4/16/2018
Job ID: 02584224
Job Description
We are looking for a Quality Assurance Auditor who has worked in a cGMP environment to be responsible for developing, maintaining and ensuring compliance.
 
Roles and Responsibilities:
  • Manage audit planning, scheduling, and execute internal audits in Facilities to assess compliance to the regulations.
  • Function as a backup as well as support the efforts of Supplier Quality Engineer.
  • 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.
  • Assist internal departments so that they are able to understand and comply with Quality and Compliance expectations.
  • Assessing the 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 Quality Assurance team.
  • Report audit metrics to Quality Assurance and department management.
  • Performance of other duties may be required for meeting compliance requirements.
  • Regular Attendance is required.
  • Communicate effectively with other departments within the organization and function within a team environment.
  • Perform other assigned duties as may be required in meeting company objectives
Minimum Requirements:  
  • Knowledge of the Regulations 21 CFR 507 as well as 21 CFR 111.
  • Must have a minimum of 5years of experience in Quality Assurance including Supplier Quality Management.
  • ASQ Certified Auditor (CQA) Certification is preferred.
  • Experience auditing for compliance.
  • Strong knowledge of GMP manufacturing regulations.
Education and Experience: 
B.A or B.S in Science or Technical Field preferred
 

Kersey & Associates, Inc.
513 Usdasdi Drive Brevard, NC 28712
Phone: 828-966-9030    Fax: 828-966-9032    Email: david@kersey.com