PDS Tech Inc QA Technician in Shawnee Mission, Kansas
PDS Tech Inc is seeking Quality Assurance, in Lenexa, KS.
The QA Technician will review batch records, identify documentation errors, and coordinate with Operations to resolve errors or escalate issues as part of the quality assessment of products. The QA Technician will also file and retrieve documents as needed. The QA Technician requires excellent attention to detail and organizational skills to ensure timely and accurate evaluation of documentation.
• Review production batch documentation for compliance with cGMP good documentation requirements.
• Communicate effectively and coordinate tasks with Manufacturing and Quality Control to ensure timely release of products.
• Process 100% inspection rework activities and stock adjustments.
• Track and trend functional metrics.
• Support Regulatory and Customer Audits.
• Support continuous improvement activities and participate in lean activities.
• High School Diploma or equivalent.
• Working knowledge of various computer software programs such as Excel.
• 1+ years of experience in QA, QC, or manufacturing within a regulated environment such as medical device, pharmaceutical, or food manufacturing.
• Background in Medical device, cGMP, or ISO certified environment.
• Data entry skills and familiarity with inventory management systems such as SAP.
• Demonstrated ability to work effectively as a member of a cross-functional team.
All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.