QC Lab Technician

Eli Lilly and Company • Us, IN

14h • Onsite

About The Position

The QC Lab Technician, Device Quality, is primarily responsible for providing technical support and expertise for work processes and activities associated with laboratory operations, performing testing in support of commercial and development product, and supporting laboratory investigations. Develop and maintain knowledge of applicable regulations, LQS, and GQS requirements in order to network and influence Lilly’s and the industry’s application. Implement, maintain, and/or enhance appropriate quality systems within IDM QC laboratory. Provide Quality Control support for the IDM QC laboratory. Author, maintain, and instruct on OJT courses for laboratory equipment, testing inspection, and laboratory operations. Perform and oversee QC laboratory equipment setup, operation, and maintenance. Build and maintain working relationships with DDR&D, TS/MS, Lilly final Device Assembly/ Packaging Sites, and Contract Manufacturers supporting batch release testing of Lilly product. Participate in new product design and pre-launch preparation projects to support laboratory operations and device testing. Participate in departmental process improvement activities. Maintain IDM QC laboratory inventory management. Assist in equipment qualification testing activities including IQ, OQ, and PQ. Maintain and manage the reference sample retention area. Support and perform laboratory device testing for commercial and development product using good documentation practices. Perform test equipment setup, operation, and maintenance. Support shipping and receiving activities as assigned. Create/Edit lot release workshops as needed. Maintain laboratory notebooks, including authoring, revision, and retirement Participate in regulatory agency and internal inspections. Ensure that all test equipment is properly validated and maintained for its intended use. Support Event Management through roles of originator and executor of deviations impacting the QC laboratory, including origination of SARE as appropriate. Support Change Management through roles of originator and/or executor of tasks and implementation steps.

Requirements

• High school diploma or GED required
• Minimum of 2 years of regulated industry experience with demonstrated knowledge of related quality systems and regulatory requirements (e.g., cGMP, 21CFR820, ISO 13485, ISO 194971, Canadian MDR, EU Medical Device Directive, JPAL)
• Qualified candidates must be legally authorized to be employed in the United States.
• Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.

Nice To Haves

• Some post-secondary education or associates degree preferred
• Three years experience in Quality or TS/MS support
• Strong problem solving and analytical thinking skills
• Experience with Parenteral products, dry products, or devices
• Experience with Veeva and TrackWise
• Strong verbal and written communication skills in English
• Self-management / motivated
• Experience in Outlook, Windows, and Microsoft applications
• Excellent teamwork and ability to multi-task.
• Strong curiosity skills with the ability to question/identify issues and work to resolution
• Strong critical thinking/problem solving skills with an ability to apply rationale
• Attention to detail
• Ability to mentor/train others - share learning.

Responsibilities

• Provide technical support and expertise for work processes and activities associated with laboratory operations.
• Perform testing in support of commercial and development product.
• Support laboratory investigations.
• Develop and maintain knowledge of applicable regulations, LQS, and GQS requirements.
• Implement, maintain, and/or enhance appropriate quality systems within IDM QC laboratory.
• Provide Quality Control support for the IDM QC laboratory.
• Author, maintain, and instruct on OJT courses for laboratory equipment, testing inspection, and laboratory operations.
• Perform and oversee QC laboratory equipment setup, operation, and maintenance.
• Build and maintain working relationships with DDR&D, TS/MS, Lilly final Device Assembly/ Packaging Sites, and Contract Manufacturers supporting batch release testing of Lilly product.
• Participate in new product design and pre-launch preparation projects to support laboratory operations and device testing.
• Participate in departmental process improvement activities.
• Maintain IDM QC laboratory inventory management.
• Assist in equipment qualification testing activities including IQ, OQ, and PQ.
• Maintain and manage the reference sample retention area.
• Support and perform laboratory device testing for commercial and development product using good documentation practices.
• Perform test equipment setup, operation, and maintenance.
• Support shipping and receiving activities as assigned.
• Create/Edit lot release workshops as needed.
• Maintain laboratory notebooks, including authoring, revision, and retirement.
• Participate in regulatory agency and internal inspections.
• Ensure that all test equipment is properly validated and maintained for its intended use.
• Support Event Management through roles of originator and executor of deviations impacting the QC laboratory, including origination of SARE as appropriate.
• Support Change Management through roles of originator and/or executor of tasks and implementation steps.

Benefits

• company bonus (depending, in part, on company and individual performance)
• company-sponsored 401(k)
• pension
• vacation benefits
• medical, dental, vision and prescription drug benefits
• flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
• life insurance and death benefits
• certain time off and leave of absence benefits
• well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED