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Quality Assurance Representative- Parenteral

Durham, North Carolina

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Req ID R-19433 Title Quality Assurance Representative- Parenteral City Durham State / Province North Carolina Country United States Region Research

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 35,000 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.

Lilly is designing and building a new state of the art Parenteral, Device Assembly, and Packaging Facility in Raleigh-Durham North Carolina.  This is an exciting opportunity to help build a state-of-the-art facility and Quality System from the ground up. 

The Quality Assurance Representative for the Parenteral team (preparation, formulation, filling, visual inspection) provides daily oversight, assistance, and guidance to issues such as non-conformance investigations, change control proposals, procedures / master formula revisions, validations, sterility assurance, commissioning, and qualification activities. The Quality Assurance Representative position is essential for maintaining GMP compliance and providing support during preparation for Pre-Approval/General Inspections by various regulatory agencies.

Key Objectives/Deliverables:

  • Responsible for adhering to safety rules and maintaining a safe work environment for both yourself and others by supporting HSE corporate and site goals.
  • Lead, mentor, and coach operations and support personnel on quality matters.
  • Ensure regular presence in drug product preparation and formulation areas to monitor GMP programs, and quality systems.
  • Active on local process teams or indirect participation through project support activities.
  • Ability to assess and triage deviations / observations that occur within Drug product preparation and formulation areas.
  • Work with Lilly support groups and external partners to resolve or provide advice on product related issues. 
  • Participate in self-led inspections and provide support during internal / external regulatory inspections.
  • Effectively review and / or redline to ensure quality attributes are met.

(i.e, deviations / observations, procedures, technical studies, validation protocols, change controls, and engineering documents).

  • Participate in Six Sigma Projects to help improve productivity within the local process team or quality organization.
  • Support project and process improvement initiatives for Plant Process Teams as representative of the Quality function.
  • Approve commissioning qualification / validation documents for computer systems and equipment to ensure compliance with quality standards.

Minimum Requirements:

  • Minimum of 5 years experience in GMP facility.
  • Demonstrate attention to detail, strong oral and written communication and interpersonal skills.
  • Demonstrated decision making and problem-solving skills.
  • Demonstrate knowledge and understanding of aseptic manufacturing process, visual inspection, and Quality Systems.
  • Proficiency with computer systems including Microsoft office products, SAP, Trackwise, etc.
  • Proven ability to work independently or as part of a team to resolve issues.
  • Ability to work 8 hour days – Monday through Friday.
  • Ability to work overtime as required.
  • Ability to work on a 3 – 6 month short term assignment in Indianapolis, IN.
  • In addition, ability to travel up to 10% to Indianapolis, IN for meetings and coordination within applicable Lilly organizational units.

Additional Preferences:

  • Previous work in drug product or drug substance aseptic manufacturing including barrier technology with experience with US/EU regulations and notified bodies.
  • CQE, or CQA certification from the American Society for Quality (ASQ)
  • CSQA experience
  • Previous experience in GMP aseptic production environments and sterility assurance concepts
  • Previous facility or area start up experience.

Education Requirements:

  • Bachelor’s degree in a science, engineering, computer, or pharmaceutical related field of study or equivalent industry experience.

Other Information:

  • May be required to respond to operational issues outside of core business hours / days.
  • Applicant may work in various areas within the Parenteral building. Mobility requirements should be considered when applying for this position.
  • The position is for the Lilly Research Triangle Park site and during the project phase will allow for a flexible working environment will the ability to periodically work remotely based on the project phase and site activities.
  • Position requires a short duration assignment of 3-6 months in Indianapolis to establish specific aseptic fill/finish knowledge and establish global contacts.

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.


As a condition of employment with Eli Lilly and Company in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide valid proof of vaccination to the company.
 

To submit resume, visit https://www.lilly.com/careers and apply to Req ID R-19433.

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.

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