QA Associate/Quality Analyst/Manufacturing

$49,920 - $54,080/Yr

Techmatrix Pte Ltd - Winchester, KY

Full-time - Entry Level

Winchester, KY

Educational Services

About the position

The QA Associate is responsible for providing quality support functions in the manufacturing of solid oral dosage products. This role involves oversight of manufacturing operations, ensuring compliance with cGMP, CFR, and Catalent SOP through document review, real-time monitoring, and testing of in-process and finished products. The position is essential for maintaining quality standards and facilitating process improvements within the manufacturing environment.

Responsibilities

• Oversee manufacturing operations through document review and approval.
• Monitor and approve manufacturing activities in real-time.
• Test and approve in-process and finished product samples.
• Recommend changes to SOP and batch records as needed.
• Perform real-time audits of batch records for completeness and compliance.
• Conduct microbial swabbing for environmental monitoring.
• Maintain understanding of Catalent SOPs and applicable cGMP and CFR guidance.
• Perform routine testing of in-process and finished product samples.
• Monitor production areas for compliance with SOP/cGMP/batch records and safety requirements.
• Initiate deviation problem reports in Trackwise for QA-discovered issues.
• Manage quality status of WIP and finished goods in inventory systems.
• Assist in investigations for deviations and support root cause analysis.
• Provide training and coaching to manufacturing staff as needed.

Requirements

• Six Sigma Certification
• cGMP experience
• CAD experience
• GMP experience
• Mid-level experience with Minitab
• High school diploma or GED
• Bachelor's degree in a related field
• 1 year of environmental monitoring experience
• 4 years of manufacturing experience
• 2 years of relevant work experience in a regulated GMP environment

Nice-to-haves

• Lean Six Sigma certification
• ASQ certification or other professional certifications

Benefits

• Health insurance
• Dental insurance
• 401(k)
• Paid time off
• Vision insurance
• 401(k) matching
• Life insurance