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Job Type:
Full-time

Industry:

Company: Eli Lilly and Company

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Organization Overview:
Drug Product External Manufacturing – US (DPEM) Quality Assurance assures patients worldwide of safe and efficacious drug products, through effective quality oversight of North, Central and South American contract manufacturers and alliance partners. This oversight covers the process steps of selection, pre-validation/validation, ongoing operations and termination. DPEM Quality Assurance is committed to creating partnerships that facilitate open communication and maintaining effective relationships with our alliance partners, contract manufacturers, and internal business customers.

Responsibilities:
The QA Associate for Batch Release is responsible for final disposition of manufactured and packaged drug product batches. This role ensures that all batches meet specifications, are manufactured/packaged in accordance with validated processes and are compliant with cGMP requirements and regulatory requirements.

  • Complete batch record and media fill reviews, reporting any issues
  • Determine final disposition of batches by reviewing all required documentation including but not limited to change controls and deviations
  • Originate and investigate deviations associated with batch records
  • Work with Lilly support groups to resolve product related issues
  • Participate in the creation and revision of standard operating procedures, Master Batch Records and Master Packaging Orders
  • Create Certificates of Analysis or other similar documentation for internal and external customers
  • Review and approve documentation that supports manufacturing (e.g., deviations, changes, procedures, protocols), as applicable.
  • Assist in the establishment and revisions of Quality Agreements with affiliates and customers.
  • Provide support to ensure on time completion of Annual Product Reviews
  • Provide support to launch new products/ packages/ contract manufacturers (CMs)
  • Participate on Joint Process Teams
  • Maintain material management (e.g. check all API restrictions in SAP and apply those restrictions to finished product)
  • Provide support for Notification to Management data gathering
  • Provide input for metrics reports to management
  • Complete process/productivity improvements and compliance projects as assigned
  • Oversee the batch release qualification process, benchmark with internal organizations, and implement improvements
  • Contribute to Quality culture efforts at both DPEM and CM
  • Complete other duties as assigned

Basic Requirements:

  • Bachelor’s Degree in a science related field such as Engineering, Pharmacy, Chemistry, Biological Sciences or related Life Sciences or equivalent experience
  • Minimum 3 years of experience in regulated manufacturing industry and/or quality experience; parenteral experience preferred

Additional Skills/Preferences:

  • Proven ability to work independently or as part of a Team to problem solve
  • Experience with Pharma industry electronic systems (SAP, Trackwise, Regulus)
  • Previous experience with batch disposition for drug product manufacturing and packaging processes
  • Technical understanding of cGMPs and the Global Quality Standards
  • Knowledge of Pharmaceutical Manufacturing Operations
  • Strong written and verbal communication skills
  • Teamwork and interpersonal skills exhibited across functional areas
  • Ability to organize, prioritize, multi-task, and influence diverse groups
  • Strong decision making and problem-solving skills

Additional Information:

  • Shift is days, but off-hours may be necessary to support operations
  • Travel is possible, up to 10%
  • This position is an onsite position that requires you to be onsite the majority of the time. This is not a remote position. Position is based out of Indianapolis, IN at Lilly Corporate Center.

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

#WeAreLilly

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