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Quality Assurance Auditor (Pharma)
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Job Location: Lancaster, SC
JOB DESCRIPTION

Job #: 10775
Title: Quality Assurance Auditor (Pharma)
Job Location: Lancaster, South Carolina - United States
Employment Type:
Salary: $50,000.00 - $60,000.00 - US Dollars - Yearly
Employer Will Recruit From: Regional
Relocation Paid?: NO

WHY IS THIS A GREAT OPPORTUNITY?

We are looking for a Quality Assurance Auditor who has worked in a cGMP environment to be responsible for developing, maintaining and ensuring compliance.

JOB DESCRIPTION

  • 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
QUALIFICATIONS

  • 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.

  • B.A or B.S in Science or Technical Field preferred

Education:
None


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