Fort Worth Metro Area, TX
Safety/Housekeeping - Keep work areas clean and free of hazards or dangerous conditions
Promote/reinforce company and department HSE standards, through regular communication, training, and reminders.
Ensure associates work according to established standards and SOPs
Ensure work areas are clean and safe, and audit-ready at all times.
Continuously monitor work areas; identify, resolve, and report safety hazards.
Ensure materials are handled and disposed of properly, per HSE standards.
Planning - Ensure production inspection and review responsibilities are completed on time to meet schedules.
Balance line inspection coverage for multiple manufacturing lines by multitasking and prioritizing work load
Ensure MBR reviews are completed in a timely manner based on scheduled due dates
Technical - Perform activities that ensure required quality and safety standards are being met for our products.
Audit production lots to ensure products manufactured are in compliance with corporate, regulatory and industry standards.
Verify all variable coding prior to initiating production
Perform Inspection By Attribute testing to detect particulates and/or product defects
Review non-conformities found during the manufacturing process to assess need for mechanical intervention and/or product hold.
Pull analytical samples for chemistry and microbiological testing
Pull, log, and inspect retention samples
Review MBRs to ensure all manufacturing batch procedures are followed and all data is recorded per procedure.
Review and approve autoclave charts for verification of critical parameters and correct load configurations
Lot MBRs into computer tracking system and file pending review
Review and approve filter integrity tests
Verify entries in inventory/release systems in relation to expiration dating and completed quantities
Enter and verify test results in Laboratory management system
Approve release of intermediate product for further processing either in house or at a 3rd party facilities
Team - Cooperate and support coworkers to enhance overall capability of the organization
Participate in problem solving and troubleshooting when assessing product non-conformities and non-routine situations
Demonstrate overtime flexibility
Support training needs of team members
Work cohesively with team
Interfaces - Coordinate/support other departments to ensure smooth execution of work
Communicate effectively with production, maintenance, warehouse, and other functions as necessary to ensure all products meet required quality and safety standards in line with production and product release schedules
Minimum Skills: Experience in QA, Technical Operations, and/or manufacturing in GMP regulated environment
Ability to work under pressure, perform multiple tasks, while maintaining organization and attention to details
Computer, Microsoft Office
Company specific systems such as ARMS, LIMS, DCM, Trackwise, etc.
Individual and Team Contributor
Deadlines under pressure
High School Diploma