Quality Control Technician I
6201 South Freeway Fort Worth, TX 76134 US
Job Description
- 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
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
Education:
- Bachelors Degree in Science or Engineering
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