QA Associate – Dry External Intermediates Manufacturing
Eli Lilly and Company
Associate Director – Analytical Quality Assurance
Eli Lilly and Company
full-time
Posted on:
Location Type: Office
Location: Indianapolis • 🇺🇸 United States
Visit company websiteSalary
💰 $123,000 - $180,400 per year
Job Level
Senior
About the role
- Lead a team of people which includes coaching/feedback for performance and development of QA employees as well as recruiting new talent
- Support the cross-functional teams, facilitate decision making, drive progress, establish key performance indicators for work area and monitor effectiveness
- Translate global quality standards, cGMP, and regulatory requirements into site-level procedures
- Facilitate decision making within the team under tight deadlines
- Effectively communicating and managing internal and external stakeholders
- Proactively managing issues, proposing, and implementing plans to resolve as needed
- Provide quality oversight in Analytical testing, namely: molecule support, qualification of new contract labs, audit support, quality system ownership, leading compliance projects for analytical within the Foundry, and quality assessments of quality documentation (e.g., deviations, change records)
- Ensure that appropriate quality systems are in place and are being utilized
- Facilitate quality improvement initiatives, and the implementation of new quality standards
- When necessary, evaluate potential impact of incidents on quality of materials, or the integrity of data
- Coach/mentor others regarding investigations are conducted for deviations, stability failures and out of specification (OOS) results
- Review and approval of the corresponding documentation
- Network with Lilly quality organizations in the implementation of quality laboratory systems and share best practices
- Promote a positive quality culture and oversee quality presence in the respective laboratory areas
Requirements
- Bachelor’s degree in Chemistry, or related field
- Minimum of 5 years in laboratories and analytical testing and/or quality experience in the pharmaceutical industry, preferred
- Relevant industry experience in highly paced working environments
- Relevant experience of working on large-scale capital project deliveries is highly desirable
- Strong knowledge of the current GMP expectations and application of quality management systems in execution
- Previous management experience with responsibilities including performance evaluations and personnel development
Benefits
- Eligibility to participate in a company-sponsored 401(k)
- Pension
- Vacation benefits
- Eligibility for 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)
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
analytical testingquality oversightquality system ownershipcompliance projectsquality assessmentsdeviationschange recordsinvestigationsstability failuresout of specification (OOS)
Soft skills
coachingfeedbackdecision makingcommunicationstakeholder managementissue managementproactive managementmentoringnetworkingpromoting quality culture
