Job Description

Position Overview: We are seeking a detail-oriented and experienced Pharmaceutical QA/QC Auditor to join our Quality Assurance (QA) and Quality Control (QC) team. The primary responsibility of this role is to perform audits of manufacturing, testing, and quality systems to ensure compliance with regulatory requirements, industry standards, and company policies. The ideal candidate will have a strong background in pharmaceutical quality assurance and quality control, with experience in auditing manufacturing facilities, laboratories, and suppliers.

Key Responsibilities:

  • Conduct internal and external audits of manufacturing facilities, testing laboratories, and suppliers to assess compliance with cGMP regulations, company policies, and industry standards.
  • Develop audit plans, schedules, and checklists based on regulatory requirements and risk assessments.
  • Perform thorough evaluations of quality systems, processes, procedures, and documentation to identify areas of non-compliance or improvement opportunities.
  • Review batch records, testing data, and other documentation to ensure accuracy, completeness, and compliance with established standards.
  • Prepare detailed audit reports documenting findings, observations, and recommendations for corrective and preventive actions (CAPAs).
  • Communicate audit findings and recommendations to management and stakeholders, facilitating discussion and resolution of identified issues.
  • Follow up on corrective actions and CAPAs to verify implementation and effectiveness.
  • Provide support and guidance to manufacturing, testing, and quality control teams on compliance-related matters.
  • Stay informed about current regulations, guidelines, and best practices in pharmaceutical quality assurance and quality control.

Qualifications:

  • Bachelor's degree or higher in Pharmacy, Chemistry, Biology, or related field.
  • Minimum 3 years of experience in an auditing roles with nowledge of QA/QC practices
  • Strong understanding of cGMP regulations, FDA guidelines, and international regulatory requirements governing pharmaceutical manufacturing and testing.
  • Experience conducting audits of manufacturing facilities, testing laboratories, and suppliers in accordance with regulatory requirements and industry standards.
  • Excellent auditing skills, with the ability to analyze complex systems and processes, identify non-conformities, and make appropriate recommendations for improvement.
  • Effective communication and interpersonal skills, with the ability to interact confidently with all levels of personnel and management.
  • Detail-oriented with strong analytical and problem-solving skills.
  • Professional certifications such as Certified Quality Auditor (CQA) or Certified Pharmaceutical GMP Professional (CPGP) are preferred but not required.

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Job #:
26499962
Position Type:
Direct Placement
Location:
Lincolnton, NC
Flexibility:
Onsite

 
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