The QA Associate will play a vital role in ensuring quality support for the manufacturing of solid oral dosage products. This position involves overseeing manufacturing operations in compliance with cGMP, CFR, and SOP standards through document review, real-time monitoring, and approval of both in-process and finished product samples.
Key Responsibilities:
SOP and Batch Record Management:
Recommend changes to SOPs and batch records as needed.
Review proposed SOP revisions and provide constructive feedback.
Manufacturing Oversight:
Conduct real-time audits of batch records for completeness, documentation accuracy, and adherence to critical process parameters.
Perform room and equipment clearances following cleaning procedures.
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.
Monitor production areas for compliance with SOPs, cGMP, and safety standards to identify and rectify potential issues.
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.
Manage the quality status of work-in-progress (WIP) and finished goods in both physical inventory and the JD Edwards inventory system.
Problem Reporting and Investigation:
Initiate deviation problem reports in Trackwise, detailing incidents for thorough investigations.
Assist in investigations of deviations through data collection and root cause analysis.
Team Collaboration:
Promote teamwork and effective communication across departments.
Provide training and coaching to manufacturing staff as needed.
Support site process improvements, including training initiatives and efficiency projects.
Customer Complaint Support:
Participate in customer complaint investigations by inspecting retained samples and addressing issues.
Essential Skills and Experience:
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.