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QA Representative: Eli Lilly and Company

For more than 130 years, Lilly has been dedicated to meeting the health care needs of people in the United States and around the world. We address these needs primarily by developing innovative medicines—investing a higher percentage of our sales in research and development than any other major pharmaceutical company. If you are interested in being considered for employment with a “Best in Class” Pharmaceutical company, please review the following opportunity:
QA Representative-Fixed Duration Employee
The Quality Assurance Representative performs a wide variety of Quality Assurance functions and oversight for Clinical and Development API manufacturing in B110 Chemical Product Research & Development (CPR&D).Key Responsibilities: Significant support and oversight with regard to Starting Materials, Intermediates and API manufacturing Ensuring operations appropriately addresses issues identified during manufacturing campaigns (including an assessment of the impact of deviations, changes, and complaints) Participating in appropriate technical and meetings Providing phase appropriate guidance on quality topics Networking with supporting quality representatives, when appropriate, ensuring goals and objectives are understood and met Ensuring an appropriate control strategy (as defined by the phase of development) is in place for the process Communicating project information/quality issues to Quality Management supporting senior level review of the project Evaluating and promoting consistency across teams Assisting with transferring process knowledge to Commercial QA Unit.This position is not permanent. It is for a fixed duration of up to 4 years.
KEY OBJECTIVES/DELIVERABLES:

• Quality Leadership: The Quality Assurance Representative provides leadership in establishing and maintaining Quality Systems. The Quality Assurance Representative ensures appropriate execution of the Quality Systems to sustain a state of current Good Manufacturing Practices (cGMP) compliance. Quality Assurance Representatives are also responsible for appropriate notification to management of quality issues.
• Quality Functions and Quality System Oversight: The Quality Assurance Representative is responsible for the quality functions as they relate to development and clinical trial operations. Responsibilities include batch disposition, review and approval of cGMP documents, investigation and reconciliation of deviations, compliance auditing, internal auditing and cGMP education. The Quality Assurance Representative facilitates implementation of local Development Quality Systems and Standard Operation Procedures. The Quality Assurance Representative works closely with Quality Assurance specialists, building engineers, technical services, scientists, operations and maintenance to assure that manufactured materials meet specifications and have been produced according to registration requirements and cGMPs.
• Quality Consultation / Inspection Readiness: The Quality Assurance Representative teams with Corporate Quality Assurance and Regulatory to interpret and apply regulations, policies and guidelines. The Quality Assurance Representative is an active participant in audits and inspection readiness activities to ensure the site is in a constant state of inspection readiness.
• Quality Continuing Education: The Quality Assurance Representative is responsible for maintaining current knowledge of GMPs through avenues such as participating in seminars or conferences and reading applicable journals and other article store main current with industry standards and trends. The Quality Assurance Representative is also responsible for completing individual training courses and requirements according to their individual training plan.
  

MINIMUM REQUIREMENTS:

• Bachelors Degree in Biology, Chemistry, Bio-Chemistry, Microbiology, Pharmacy, Engineering or similar.
• Working knowledge of GMPs.
• Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.
  

ADDITIONAL SKILLS/PREFERENCES:

• Advanced Degree Biology, Chemistry, Biochemistry, Microbiology, Pharmacy, Engineering, or other related science or relevant work experience in the area of Quality Assurance/Quality Control.
• 3+ years experience in pharmaceutical operations preferred.
• Quality Assurance experience preferred.
• Working knowledge of cGMP auditing experience strongly preferred.
• Deep knowledge of product development preferred.
• Technical expertise in late phase API and/or Drug Product manufacturing preferred.
• Knowledge of chemical API manufacturing processes strongly preferred.
• Understanding of Quality by Design principles and control strategy a plus.
• Batch review and disposition experience preferred
• Excellent problem solving and decision making ability.
• Strong communication( oral and written ) and interpersonal skills.
• Demonstrated attention to detail.
• Must demonstrate excellent analytical and problem solving skills.
• Positive and professional approach.
• Detail oriented.
• Prioritization.
• Flexibility.
  

OTHER CONSIDERATIONS:

• 15-20% travel both domestic and International.
  

Lilly credits its exceptional employees for its successes, and knows the key to ongoing achievement lies in attracting and retaining the best people. A company rich in heritage, Lilly employs individuals, conducts research and markets products worldwide. By providing for the unmet needs of our customers through a continuous stream of innovation, we will outgrow all competitors.
Lilly earns consistent and wide recognition for creating an exceptional work environment while maintaining our highly regarded reputation in the Pharmaceutical Industry and Community:

• FORTUNE Most Globally Admired Companies™
• FORTUNE Top Companies for Leaders in North America™
• Chronicle of Philanthropy Most Generous Companies in the US
• Business Week Magazine Best Places To Launch A Career™
• Information Week 500 Most Innovative Users of Technology
• Science Magazine Best Companies for Scientists™
• The ScientistBest Places to Work in the Industry™
• Black Enterprise Top 40 Companies for Diversity
• Working Mother Best Companies for Working Mothers™
  

LILLY IS AN EQUAL OPPORTUNITY EMPLOYER