Quality Assurance Associate
13 hours ago
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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