Overview
Quality Assurance Representative – Parenteral Jobs in Durham, North Carolina, USA at 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 worldwide work to discover and bring life-changing medicines to those in need, improve disease understanding and management, and give back through philanthropy and volunteerism. We prioritize our work and people, seeking individuals determined to improve lives globally.
Responsibilities:
Oversee daily activities of the Parenteral team (preparation, formulation, filling, visual inspection), including non-conformance investigations, change control proposals, and validation activities.
Support site readiness plans, focusing on development fill operations and new system startups.
Review and approve GMP documents to ensure quality standards are met.
Participate in process teams and support project activities.
Lead and mentor team members on quality issues.
Assess deviations in drug product filling and visual inspection processes.
Ensure robust quality systems and GMP compliance.
Support process improvements and validate equipment and processes.
Coordinate with internal and external partners on product issues.
Participate in inspections and ensure safety compliance.
Basic Requirements:
Bachelor’s degree in Science or Engineering (preferred).
At least 5 years GMP facility experience.
Preferred
Skills and Experience:
Knowledge of aseptic manufacturing, isolator technology, and quality systems.
Strong decision-making, communication, and teamwork skills.
Experience with regulatory inspections and validation systems.
Proficiency with manufacturing and laboratory information systems.
CQA or CSQA certification preferred.
Proficiency in Microsoft Office.
Ability to work independently and collaboratively.
Additional Information:
Support for 24/7 manufacturing operations.
Flexible remote work options (2-4 days/month).
Lilly is committed to diversity and inclusion and provides accommodations for applicants with disabilities. For assistance, complete the workplace accommodation form.
We are an Equal Opportunity Employer. Compensation varies based on education, experience, and location, with an expected range of $63,000 – $162,800. Benefits include a 401(k), pension, health coverage, wellness programs, and more.
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Title: Quality Assurance Representative – Parenteral
Company: Lilly and Company
Location: Durham, North Carolina, USA
Category: Quality Assurance – QA/QC, Healthcare (Medical Science, Data Scientist)
