Quality Assurance Specialist

3 days ago

Durham, North Carolina, United States Lilly Full time
Job Title: Quality Assurance Representative

Lilly is a global healthcare leader seeking a Quality Assurance Representative to join our team. As a Quality Assurance Representative, you will play a critical role in ensuring the quality and safety of our products.

Job Summary:

The Quality Assurance Representative will be responsible for maintaining a safe work environment, leading safety initiatives, and working safely and accountable for supporting all HSE Corporate and Site Goals. This individual will also teach, mentor, and guide site quality personnel on sterility assurance related matters in partnership with Sterility Assurance Subject Matter Experts and Management.

Responsibilities:
  • Maintain a safe work environment, leading safety initiatives, and working safely and accountable for supporting all HSE Corporate and Site Goals.
  • Teach, mentor, and guide site quality personnel on sterility assurance related matters in partnership with Sterility Assurance Subject Matter Experts and Management.
  • Lead the quality oversight program for aseptic operations, including developing training material for aseptic observation and teaching and mentoring QA floor support and Sr. QA floor specialists in aseptic processing quality and compliance attributes.
  • Partner with TS/MS Sterility Assurance and the Learning & Development Organization to design, develop and implement the overall site training & qualification program related to aseptic operations.
  • Support knowledge development for the Quality organization related to sterility assurance expertise.
  • Participate in site inspection readiness by preparing SMEs on Sterility Assurance topics and participate in regulatory and internal audits including response to observations/recommendations.
  • Write, review and/or approve documents related to sterility assurance and microbiological related topics, ensuring they are aligned with regulatory expectations, internal standards and industry practices.
  • Assist with troubleshooting and investigations related to significant sterility assurance and / or microbiological matters.
  • Escalate sterility assurance quality concerns, inspection risks or strategic misalignment issues to site Quality Leader and the Site Lead Team.
  • Establish a strong communication and cross-functional team to work with the plants and TS/MS Sterility Assurance for microbiological and Sterility Assurance related topics. Provide inputs to the continuous improvement efforts.
  • Participate in the Site Quality Lead Team (SQLT) and other cross functional governance bodies, as applicable.
  • Network and benchmark with other sites to identify best practices and optimize site processes related to Sterility Assurance. Participate in global and network harmonization groups and projects.
  • Foster a strong quality culture including maintaining open communications and promoting teamwork and employee participation in the work group.
Requirements:
  • 7+ years directly supporting aseptic manufacturing, sterility assurance, environmental monitoring or equivalent roles.
  • Bachelor degree in biological science (microbiology/applied microbiology preferred).
Preferred Skills:
  • Previous experience in creation or management of Contamination Control Strategies.
  • Previous facility or area start up experience.
  • Previous equipment qualification and process validation experience.
  • Previous experience with highly automated parenteral manufacturing processes including isolators, automated inspection, etc.
  • Previous experience with Manufacturing Execution Systems and electronic batch release.
  • CQM, CQE, or CQA certification from the American Society for Quality (ASQ).
  • Previous experience with Trackwise, Veeva, MODA.
  • Previous experience leading or working effectively with a cross functional group.
  • Strong knowledge of Quality Management Systems and applicable regulatory requirements.
  • Technical understanding of sterility assurance, from a science and compliance perspective. Current in technological and compliance developments across the industry (e.g. filling technology, Annex 1 interpretation).
  • Previous regulatory inspection readiness and inspection execution experience.
  • Excellent interpersonal, written and oral communication skills.
  • Strong technical aptitude and ability to train and mentor others.
Additional Information:
  • Ability to work 8-hour days - Monday through Friday.
  • Ability to work overtime as required to support 24/7 operation.
  • Ability to travel up to 10% to Indianapolis, IN for meetings and coordination with global organizations.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form for further assistance.

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.

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