Senior Quality Engineer
Bridgestone Americas
QA Associate – Dry External Intermediates Manufacturing
Eli Lilly and Company
full-time
Posted on:
Location Type: Office
Location: Indianapolis • 🇺🇸 United States
Visit company websiteSalary
💰 $65,250 - $169,400 per year
Job Level
JuniorMid-Level
About the role
- Serve as a liaison between CMs and Lilly
- Provide quality oversight of CMs including being the initial point of contact for all quality-related issues
- Escalate quality issues at CMs to Lilly QA management
- Assist in the establishment and revisions of Quality Agreements with affiliates and customers
- Ensure compliance to Quality Agreements and Manufacturing Responsibilities Documents (MRDs)
- Provide quality oversight of Lilly/Dry-EM Quality Plans
- Coordinate and perform QA responsibilities of API shipments
- Participate in regulatory inspection preparations with CMs
- Provide on-site support during inspections
- Participate on the Technical Review Board
- Evaluate and disposition batches of intermediate, if required
- Ensure that documented checks have been completed for the Certificates of Testing and Certificates of Environmental Monitoring (where applicable), and deviations, changes and batch documentation that demonstrates requirements have been met prior to batch release
- Provide quality support of the manufacturing process for intermediates (such as Spry dry dispersion technology) with the focus on holistic review of key activities associated with or impacting the manufacturing processes including deviations, change controls and countermeasures
- Assess the impact of deviation investigations and changes and ensure that all appropriate records are documented and retrievable
- Ensure all processes are in an appropriate state of control
- Maintain awareness of external regulatory agency findings which individually or collectively reference the quality of the product
- Review and approve documents including, but not limited to, procedures, master production records, change control proposals, deviations, equipment qualifications, analytical methods and computerized system validations
- Participate in APR activities
- Participate in projects to improve productivity
- Participate in Joint Process (JPT) and Post Launch Optimization (PLOT) Teams
Requirements
- BS in a science-related field such as Pharmacy, Chemistry, Biological Sciences or related Life Sciences
- 3+ years of GMP manufacturing knowledge and/or experience in API/intermediates or finished product manufacturing, QC, QA or Engineering
- Experience in quality support for Quality Control activities
- Thorough technical understanding of quality systems and regulatory requirements
- Knowledge of pharmaceutical manufacturing operations
- Demonstrated coaching and mentoring skills
- Experience in root cause analysis
- Demonstrated application of statistical skills
- Demonstrated strong written and verbal communications skills
- Strong attention to detail
- Proficiency with computer system applications
- Excellent interpersonal skills and networking skills
- Ability to organize and prioritize multiple tasks
- Ability to influence diverse groups and manage relationships
Benefits
- Eligibility to participate in a company-sponsored 401(k)
- Pension benefits
- 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
GMP manufacturingAPI manufacturingQuality ControlQuality Assuranceroot cause analysisstatistical skillsquality systemsregulatory requirementspharmaceutical manufacturing operationsdocument review
Soft skills
coachingmentoringwritten communicationverbal communicationattention to detailinterpersonal skillsnetworking skillsorganizational skillsprioritizationinfluencing