Sr. Associate, QA Analytical (R2 – R3)
About The Position
Eli Lilly and Company seeks a Sr. Associate, QA Analytical (R2 – R3), to provide quality assurance analytical oversight for Product Research & Development (PR&D) and associated collaboration partners. Provide quality oversight for molecule testing labs, analytical equipment, perform audits and lab walkthroughs, and assessments of quality documentation and data. Ensure that quality systems are in place, utilized, and in a state of control. Facilitate quality improvement initiatives, and the implementation of new quality standards. Assess potential impact of incidents and ensure appropriate review is conducted for deviations, change controls, and out of specification results. Perform quality assurance review of GMP documentation and ensure compliance with internal standards and applicable regulations.
Requirements
- Bachelor’s degree in Pharmacy, Chemistry, Life Sciences, Engineering, or a related field
- 4 years of experience with quality assurance and control in a pharmaceutical setting
- 1 year of experience with conducting comprehensive document reviews, including manufacturing batch records, quality control methods, protocols, reports, and validation documents
- 1 year of experience with review and approval of method validation and technology transfer documents in compliance with ICH and FDA guidance
- 1 year of experience with review of logbooks, QA batch disposition, and QA support
- 1 year of experience with supporting QA for contract manufacturing organizations
- 1 year of experience with reviewing and supporting QA equipment validation documents, installation qualification, operational qualification, performance qualification, and the maintenance and calibration of equipment
Responsibilities
- Provide quality assurance analytical oversight for Product Research & Development (PR&D) and associated collaboration partners.
- Provide quality oversight for molecule testing labs, analytical equipment, perform audits and lab walkthroughs, and assessments of quality documentation and data.
- Ensure that quality systems are in place, utilized, and in a state of control.
- Facilitate quality improvement initiatives, and the implementation of new quality standards.
- Assess potential impact of incidents and ensure appropriate review is conducted for deviations, change controls, and out of specification results.
- Perform quality assurance review of GMP documentation and ensure compliance with internal standards and applicable regulations.
Benefits
- company bonus (depending, in part, on company and individual performance)
- company-sponsored 401(k)
- pension
- vacation benefits
- medical benefits
- dental benefits
- vision benefits
- prescription drug benefits
- flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
- life insurance
- 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)
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What This Job Offers
Job Type
Full-time
Career Level
Senior
