Responsibility:
• Prepare chemical additives for production
• Complete QC testing for prepared chemical additives
• Perform IGI and release chemicals for use.
• Cleaning and sanitation of laboratory / QC areas
• Release of solution to production (testing, review, and SAP)
• Perform SAP transactions to hold product.
• Restriction of non-conformity product according to appropriate QMI documents.
• Perform various system suitability as necessary
• Perform routine inventory (e.g., raw materials, prepared additive solutions, lab supplies, etc) for lab, assist in ordering/requesting materials and supplies, and maintain inventory in SAP and cycle count
• Training of QC Inspectors as designated
• Accurate, concurrent, and complete documentation of test results and activities according to internal and regulatory guidelines
• Training of new or existing QC employees regarding QC procedures and use of equipment.
• Other duties as assigned.
Job Requirements:
• Must have sufficient math, communication, and writing skills.
• High school education or equivalent; Degree is preferred with at least 1 year of relevant work experience.
• Experience in Medical Device, Pharmaceutical, and/or regulated industry is preferred
• Basic understanding of computer systems (Word, Excel, Outlook, and instrument dedicated).