Quality Assurance - Qa For Qc

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.

The QA for QCL (Quality Control Laboratories) Representative provides daily oversight, assistance, and guidance to issues such as analytical investigations, deviations, change control proposals, procedure / master formula revisions, validations, commissioning, and qualification activities.  The QA for QCL position is essential for maintaining GMP compliance and providing support during preparation for Pre-Approval / General Inspections by various regulatory agencies. 

Responsibilities:

• Responsible for adhering to safety rules and maintaining a safe work environment for both yourself and others by supporting HSE corporate and site goals
• Lead, mentor, and coach QCL on quality matters
• Ensure regular presence in laboratories to monitor GMP programs and quality systems
• Active member of the lab areas they support through day-to-day presence and participation with project work
• Approve test plans and analytical investigations
• Assess and triage deviations that occur as well as approve minor deviations
• Work cross functionally with QCL, Equipment team, and Manufacturing to resolve issues while adhering to quality and documentation requirements
• Participate in self-led inspections and provide support during internal / external regulatory inspections
• Ability to effectively review and / or redline documents to ensure quality attributes are met (i.e., deviations, procedures, technical studies, validation protocols, change controls, and engineering documents)
• Participate in Lean Projects to help improve productivity within the local area
• Support project and process improvement initiatives for QCL as a representative of the Quality Function
• Approve commissioning qualification / validation documents for computer systems and equipment to ensure compliance with quality standards
• Network with Global Parenteral Network sites as resources and benchmarking sources, as applicable flexibility within job assignment
• Participate in the investigation of analytical investigations or deviations, write / review change controls, and investigate deviations as required.

Basic Qualifications:

• Bachelor’s or equivalent (Science or Engineering related degree preferred).
• Demonstrated equivalent experience in a GMP facility.

Additional Preferences:

• Demonstrate strong oral and written communication and interpersonal skills
• Demonstrated risk based decision making and problem solving skills
• Demonstrate knowledge and understanding of manufacturing processes and Quality Systems
• Demonstrate technical writing and communication skills.
• Proven ability to work independently or as part of a team to resolve an issue
• Strong attention to detail
• Experience in GMP production environments or QCL is desirable
• Previous experience with Lilly Event and Change Management processes
• Proficiency with computer systems including Microsoft Office products, Veeva, TrackWise, Darwin, SmartLab® and/or MODA.

Other Information:

• May be required to respond to operational issues outside of core business hours / days.
• Applicant may work in various areas within the Parenteral Plant. Some allergens are present in the Parenteral Plant. Mobility requirements and exposure to allergens should be considered when applying for this position.

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Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

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