Quality Assurance Analyst, Sr. - Healthcare jobs in Indiana

GENERAL PURPOSE

Provide high-level support as an administrative resource to the laboratory and quality assurance departments. Provide assistance in the development, monitoring, and maintenance of food safety and quality programs and records. Function as a resource to other quality assurance team members.

JOB DUTIES AND RESPONSIBILITIES

• Complete batch record review of various products and data entry into management software system
• Disposition products (assign/change status) in management software systems as assigned
• Review, organize, and file production records
• Perform and/or assist with root cause analysis
• Maintain company and customer required spreadsheets, records, and reports and communicate with customers as needed
• Prepare and organize records as requested for internal and external audits
• Obtain and/or issue certificates of analysis as needed
• Support and assist in the writing, reviewing, updating, and training of all documentation elements of the Quality Management System and related software
• Educate and train employees on food safety and quality topics per corporate guidelines
• Coordinate daily lab activities including training of Lab Technicians in following company processes, procedures, and SOP’s
• Complete quality walkthroughs of the facility to ensure necessary corrective actions are completed; may participate in regulatory and customer inspections
• Adhere to all DFA Quality and Safety policies and procedures and report any nonconformities
• Follow all DFA good manufacturing practices (GMP) and work in a manner consistent with all corporate regulatory, food safety, quality, and sanitation requirements
• The requirements herein are intended to describe the general nature and level of work performed by employee, but is not a complete list of responsibilities, duties, and skills required. Other duties may be assigned as required

☒ No travel required

☐ 5%-15% (1-3 times per year)

☐ 15%-25% (1-2 times per quarter)

☐ 25%-50% (up to 1 week per month)

☐ 50%-75% (up to 2 weeks per month)

☐ 75%-100% (3 weeks per month)