Scientist - Quality Assurance
Eli Lilly and Company, Durham, NC, United States
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. We are looking for people who are determined to make life better for people around the world.
Overview
The Scientist - Quality Assurance position for the Device Assembly and Packaging team provides daily oversight, assistance, and guidance to issues such as non-conformance investigations, change control proposals, procedures revisions, validations, batch disposition, commissioning, and qualification activities. The Scientist - Quality Assurance position is essential for maintaining GMP compliance and providing support during preparation for General Inspections by various regulatory agencies.
Responsibilities
Responsible for adhering to safety rules and maintaining a safe work environment by supporting HSE corporate and site goals.
Lead, mentor, and coach operations and support personnel on quality matters.
Ensure regular presence in device assembly and packaging areas to monitor GMP programs, and quality systems.
Active on local process teams or indirect participation through project support activities.
Review and approve GMP documentation, including procedures, deviations, technical reports, and change controls occurring within the device assembly and packaging areas to ensure compliance with Lilly Global Quality Standards and regulatory requirements.
Work cross-functionally with process teams for metrics reviews, operational support, and deviation management.
Participate in self-led inspections and provide support during internal / external regulatory inspections.
Effectively review and / or redline to ensure quality attributes are met. (i.e., deviations / observations, procedures, technical studies, validation protocols, change controls, and engineering documents).
Participate in projects to help improve productivity within the local process team or quality organization.
Network with global device assembly and packaging sites to share best practices, improve processes and resolve product-related issues.
Requirements (Education, Experience, Training)
Bachelor’s degree in Engineering, Life Sciences, or related field
Minimum 2 years of experience working effectively with a cross-functional group in a GMP facility
Demonstrate strong oral and written communication and interpersonal skills
Demonstrated decision making and problem-solving skills
Strong attention to detail
Preferred Attributes But Not Required
Previous work with combination products or devices with experience with US/EU regulations and notified bodies
CQE or CQA certification from the American Society for Quality (ASQ)
CSQA experience
Demonstrated knowledge and understanding of manufacturing process and Quality Systems
Proficiency with computer systems including Microsoft Office products, SAP, Veeva Quality Docs, etc.
Additional Information
Ability to work 8 hour days – Monday through Friday
Ability to work overtime as required
Accommodation information: Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form. This is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
EEO statement: Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Compensation and benefits: Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $65,250 - $169,400. Full-time employees are eligible for a company bonus (dependent on company and individual performance). Lilly offers a comprehensive benefits program (e.g., 401(k), pension, vacation, medical/dental/vision, flexible benefits, life insurance, leave benefits, well-being programs). Lilly reserves the right to amend, modify, or terminate its compensation and benefits programs at its discretion.
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Overview
The Scientist - Quality Assurance position for the Device Assembly and Packaging team provides daily oversight, assistance, and guidance to issues such as non-conformance investigations, change control proposals, procedures revisions, validations, batch disposition, commissioning, and qualification activities. The Scientist - Quality Assurance position is essential for maintaining GMP compliance and providing support during preparation for General Inspections by various regulatory agencies.
Responsibilities
Responsible for adhering to safety rules and maintaining a safe work environment by supporting HSE corporate and site goals.
Lead, mentor, and coach operations and support personnel on quality matters.
Ensure regular presence in device assembly and packaging areas to monitor GMP programs, and quality systems.
Active on local process teams or indirect participation through project support activities.
Review and approve GMP documentation, including procedures, deviations, technical reports, and change controls occurring within the device assembly and packaging areas to ensure compliance with Lilly Global Quality Standards and regulatory requirements.
Work cross-functionally with process teams for metrics reviews, operational support, and deviation management.
Participate in self-led inspections and provide support during internal / external regulatory inspections.
Effectively review and / or redline to ensure quality attributes are met. (i.e., deviations / observations, procedures, technical studies, validation protocols, change controls, and engineering documents).
Participate in projects to help improve productivity within the local process team or quality organization.
Network with global device assembly and packaging sites to share best practices, improve processes and resolve product-related issues.
Requirements (Education, Experience, Training)
Bachelor’s degree in Engineering, Life Sciences, or related field
Minimum 2 years of experience working effectively with a cross-functional group in a GMP facility
Demonstrate strong oral and written communication and interpersonal skills
Demonstrated decision making and problem-solving skills
Strong attention to detail
Preferred Attributes But Not Required
Previous work with combination products or devices with experience with US/EU regulations and notified bodies
CQE or CQA certification from the American Society for Quality (ASQ)
CSQA experience
Demonstrated knowledge and understanding of manufacturing process and Quality Systems
Proficiency with computer systems including Microsoft Office products, SAP, Veeva Quality Docs, etc.
Additional Information
Ability to work 8 hour days – Monday through Friday
Ability to work overtime as required
Accommodation information: Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form. This is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
EEO statement: Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Compensation and benefits: Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $65,250 - $169,400. Full-time employees are eligible for a company bonus (dependent on company and individual performance). Lilly offers a comprehensive benefits program (e.g., 401(k), pension, vacation, medical/dental/vision, flexible benefits, life insurance, leave benefits, well-being programs). Lilly reserves the right to amend, modify, or terminate its compensation and benefits programs at its discretion.
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