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Scientific. Clinical. Software Engineering

Quality Technician

Fort Worth Metro Area, TX

Job Type: Scientific Job Number: JN -062020-26921 Region: Fort Worth Metro Area

Job Description

Duties:

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:

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

Desired Skills:

Computer, Microsoft Office

Familiar with:

Company specific systems such as ARMS, LIMS, DCM, Trackwise, etc.

Problem solving

Individual and Team Contributor

Multi-tasking

Detail- oriented

Deadlines under pressure


Education:

High School Diploma

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