Position Name: API EM Quality Assurance Specialist
Job ID: 3113
Client: Eli Lilly and Company
Work location: 1220 W. Morris Street, Indianapolis, IN 46285 United States
Contract: 1 year (extendable) with temp-to-perm opportunity
Pay Rate: $77.97 Hourly on W2
Qualifications
At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing, and delivering medicines that help them live longer, healthier, and more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.
Join the energetic and growing Active Pharmaceutical Ingredient – External Manufacturing Organization (API-EM) that delivers a diverse portfolio of medicines essential to our patients around the world. The API EM Quality Assurance for Quality Control provides support to all QC activities at Contract Manufacturing Organizations (CMs). The QA for QC position is essential for ensuring that all QC testing is conducted in accordance with validated methods and is compliant with cGMPs and regulatory commitments.
Basic Requirements
• BS in a science-related field such as Pharmacy, Chemistry, Biological Sciences, or related Life Sciences.
• 5+ years of GMP Quality Control Laboratory knowledge and/or experience in API or finished product manufacturing, QA, or Engineering.
Additional Preferences
• Testing experience with Small Molecule
• Thorough technical understanding of quality systems and regulatory requirements relating to quality control laboratories
• 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 communication skills
• Strong attention to detail
• Proficiency with computer system applications
• Excellent interpersonal and networking skills
• Ability to organize and prioritize multiple tasks
• Ability to influence diverse groups and manage relationships
Education Requirements
• BS in a science-related field such as Pharmacy, Chemistry, Biological Sciences, or related Life Sciences.
Other Information
• Must complete required training for API EM Quality Assurance
• No certifications required
• Tasks require entering manufacturing and laboratory areas which require wearing appropriate PPE
• Must be able to support 24-hour/day operations
• Up to 20% travel (US & OUS)
Responsibilities
Key Objectives / Deliverables
• Serve as a liaison between CMs and Lilly
• Provide quality oversight of Quality Control activities at CMs, including being the initial point of contact for all quality-related issues with testing
• Provide quality oversight of CM method validation or method transfer activities
• Escalate quality issues at CMs to Lilly QA management
• Assist in the establishment and revision of Quality Agreements with affiliates and customers
• Ensure compliance with Quality Agreements and Manufacturing Responsibilities Documents (MRDs)
• Coordinate and perform quality responsibilities of API shipments for stability testing and provide oversight of the API EM stability program
• Participate in regulatory inspection preparations with CMs
• Ensure documented checks are completed for Certificates of Testing and Certificates of Environmental Monitoring (where applicable), along with deviations, changes, and batch documentation demonstrating requirements have been met prior to batch release
• Provide quality support of Quality Control, focusing on holistic review of key activities impacting quality control testing including deviations, change controls, and countermeasures
• Assess the impact of analytical deviation investigations and changes, ensuring all appropriate records are documented and retrievable
• Maintain awareness of external regulatory agency findings referencing the quality of the product
• Review and approve documents including, but not limited to:
- Analytical procedures
- Change control proposals
- Deviations
- Analytical equipment qualifications
- Analytical methods
- Computerized system validations
• Participate in APR activities
• Participate in projects to improve productivity
• Participate in Joint Process (JPT) and Post Launch Optimization (PLOT) Teams
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