Quality Environmental Monitoring/Sterility Assurance Manager Job in Indianapolis 46225, Indiana Us
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:
Quality Environmental Monitoring/Sterility Assurance Manager
The Quality Environmental Monitoring/Sterility Assurance Manager is responsible for the oversight of environmental monitoring and utilities testing (e.g., process gases, water, steam) in direct support of parenteral plant manufacturing operations including; sampling logistics and scheduling, sample and data handling and processing, investigation of potential contamination issues, sterility assurance auditing, and data analysis. The role is also responsible for coordinating execution of Environmental Monitoring Performance Qualifications for all Parenteral Plant facilities. This position requires the ability to multitask/prioritize, excellent written and oral communication skills, decision making ability, interpersonal skills, as well as the ability to anticipate potential problems then develop / implement alternative solutions.
KEY OBJECTIVES/DELIVERABLES:
- Recruit / retain effective diverse staff, supervise, coach, and aid in development, performance management, ensure a fair and equitable work environment.
- Assist in the setting of human resource and business plan goals.
- Leadership role in implementation of quality systems.
- Apply knowledge of quality principles and GMPs toward the development of local procedures.
- Define and monitor quality plan for environmental monitoring, utilities testing, and sterility assurance initiatives and projects to ensure proper priority, resources, and direction have been provided.
- Interact effectively with customer and support groups.
- Provide technical support and expertise for site and Corporate environmental monitoring, utilities testing, and sterility assurance issues.
- Ensure appropriate staffing and support is available for all Parenteral Plant manufacturing operations.
- Define and maintain inspection readiness activities.
- Network internally and externally to understand best practices, share knowledge, participate in tactical and strategic business planning, and to ensure customer needs are met.
- Interact with regulatory agencies during inspections regarding cGMP, environmental monitoring, utilities testing, and sterility assurance issues.
- Influences development of improved and streamlined quality systems.
- Serve as conduit for corporate communications/initiatives.
- Serve as technical resource and review and approve technical documents.
- Facilitates assessment of assay variability contribution to total process variability and ensure lab initiatives are aimed at reducing measurement variability.
- Serve as process change agent; manage improvement of environmental monitoring, utilities testing, and sterility assurance, operations.
- Lead projects to improve organizational effectiveness and efficiency.
- Network with other sites regarding new systems development.
- Develop plan for capital purchases.
- Facilitate the implementation of OSSCE concept, work closely with customers to ensure development of systems that will facilitate the work flow.
- Maintain open communications and promote teamwork and employee participation in the work group.
- Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.
MINIMUM REQUIREMENTS:
- Bachelors of Science degree in Microbiology or related science.
- 3-5 years supervisory experience.
- 5+ years parenteral environmental monitoring, utilities testing, and/or sterility assurance experience.
- 3-5 years experience interacting with regulatory agencies.
- In-depth understanding of microbiology principles relating to environmental monitoring and sterility assurance.
- Deep understanding of compliance requirements and regulatory expectations relating to environmental monitoring, utilities testing, and sterility assurance associated with the manufacture of parenteral products.
- 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 status) for this employment position.
ADDITIONAL PREFERENCES:
- Six Sigma Green Belt or Black Belt certification.
- Masters of Science in Microbiology or related science.
OTHER CONSIDERATIONS:
- Applicant will work in various areas within the Parenteral Plant. Some allergens are present in the parenteral plant. Mobility requirements and exposure to allergens should be considered when applying for this position.
- Tasks may require repetitive motion (e.g., keyboarding).
- Post-offer testing may be required.
- Minimal travel required.
- Ability to work 8 hour days Monday through Friday.
- Ability to work overtime as required
- Available off shift to respond to operational issues.
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. The following is a selection of awards and recognition Lilly has received in recent years:
Awards and Recognition
ELI LILLY AND COMPANY IS AN EQUAL OPPORTUNITY EMPLOYER