Technician - QC - IDM

Initial Therapeutics, Inc.; Indianapolis (IN); On-site; Full time

Job summary

An established industry player is seeking a Lead Technician for Quality Control in Indianapolis. This pivotal role involves providing technical expertise and support for laboratory equipment and batch release processes. You will be responsible for maintaining quality systems, developing training materials, and ensuring compliance with regulatory standards. If you are a motivated individual with a passion for quality assurance and a strong background in regulated industries, this is an exciting opportunity to contribute to impactful healthcare solutions. Join a dedicated team that values innovation and excellence in improving patient outcomes.

Qualifications

• 5+ years in regulated industry with knowledge of quality systems.
• Experience in developing training materials and problem solving.

Responsibilities

• Provide technical support for laboratory equipment and batch release qualification.
• Maintain quality systems and support lab investigations.

Skills

Problem Solving

Analytical Thinking

Communication Skills

Self-management

Teamwork

Critical Thinking

Education

High School diploma or GED

Post-secondary education or associated degree

Tools

QualityDocs

Trackwise

Microsoft Office Suite

Job description

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $17.30 - $39.06.

Organization Overview:

Indianapolis Device Manufacturing (IDM) is responsible for the development, commercialization, manufacture, and global technical stewardship of delivery devices used to administer many of the therapeutics in Lilly's portfolio. This includes the development and delivery of test systems and test methods in support of design verification, production, and complaint handling.

Position Brand Description:

The Lead Technician-QC-IDM is primarily responsible for providing technical support and expertise for work processes and activities associated with laboratory equipment and batch release qualification. Equipment process/activities include the development and delivery of equipment, equipment associated OJT courses, and the laboratory equipment maintenance program. Batch release process/activities include supporting lab investigations, reviewing deviations, and the development review, and instruction of procedures and training.

Key Objectives/Deliverables:

• 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 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 equipment validation and device testing.
• Participate in departmental process improvement activities.
• Maintain IDM QC laboratory testing schedule.
• Maintain IDM QC laboratory inventory management.
• Support and perform laboratory device testing for commercial and development product.
• Provide strategic and tactical support to drive technical training within laboratory operations.
• 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 an Analytical Investigation (AI) as appropriate.
• Support Change Management through roles of originator and/or executor of tasks and implementation steps.
• Review and approve OJT courses associated with laboratory operations and batch release qualification and associated workshops.

Minimum Requirements:

• Minimum of 5 years of regulated industry experience with demonstrated knowledge of related quality systems and regulatory requirements (e.g., cGMP, 21 CFR 820, ISO 13485, ISO 194971, Canadian MDR, EU Medical Device Directive, JPAL).
• Experience developing training materials.
• Strong problem solving and analytical thinking skills.
• Experience with Parenteral products, dry products, or devices.
• Experience with QualityDocs and Trackwise.
• Strong verbal and written communication skills in English.
• Self-management/motivated.
• Demonstrated computer literacy 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.

Additional Preferences:

• Three year experience in Quality or TS/MS support.
• Attention to detail.
• Experience with Microsoft Office Suite and LillyNet Collaboration Sites.
• Above average computer literacy and computer skills-specific training related to software used will be provided.
• Demonstrated knowledge and application of federal regulations as applicable to the pharmaceutical industry and related quality systems.
• Ability to mentor/train others-share learning.
• Prior experience with GMARs and maintenance of equipment or instruments.

Education Requirements: High School diploma or GED required, with some post-secondary education or associated degree preferred.

Other Information:

The position is day shift. Occasional after-hours and year-end holiday coverage may be required.

10% limited travel may be required for OUS and domestic travel.

The job responsibilities of this position support the technical ladder process.

This position is located at LTC-North in IDM.