Quality Assurance Associate

13 hours ago


Winchester, Kentucky, United States Planet Pharma Full time
Job Title: Quality Assurance Associate I

Job Summary:

We are seeking a highly motivated and detail-oriented Quality Assurance Associate I to join our team at Planet Pharma. As a Quality Assurance Associate, you will play a vital role in ensuring the quality and compliance of our manufacturing processes.

Key Responsibilities:

  • SOP and Batch Record Management:
  • Review and recommend changes to SOPs and batch records as needed.
  • Conduct real-time audits of batch records for completeness, documentation accuracy, and adherence to critical process parameters.
  • Manufacturing Oversight:
  • Monitor production areas for compliance with SOPs, cGMP, and safety standards to identify and rectify potential issues.
  • Environmental Monitoring:
  • Execute microbial swabbing of equipment and room surfaces.
  • Regulatory Compliance:
  • Maintain a comprehensive understanding of all relevant company SOPs, cGMP, and CFR guidelines.
  • Testing and Quality Management:
  • Perform routine testing of in-process and finished product samples, including particle size, bulk density, moisture analysis, appearance, and AQL testing.
  • Problem Reporting and Investigation:
  • Initiate deviation problem reports in Trackwise, detailing incidents for thorough investigations.
  • Team Collaboration:
  • Promote teamwork and effective communication across departments.

Requirements:

Education:

  • Preferred: Bachelor's Degree in a related science or technical field with 2 years of relevant experience.
  • Minimum: High School Diploma with 4+ years of relevant work experience in a regulated GMP manufacturing environment.

Additional Qualifications:

  • Lean Six Sigma, ASQ certification, or other relevant professional certifications are desirable.


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