QC Compliance Associate
Full time @Eli Lilly in Pharmaceuticals Shortlist Email JobJob Detail
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Job ID 2502
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Career Level Others
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Experience 2 Years
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Qualifications Degree Bachelor
Job Description
Eli Lilly is currently seeking a QC Compliance Associate to join our team!
About:
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 39,000 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.
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 39,000 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.
Job Summary:
The QC Compliance Professional works with leadership to implement and maintain laboratory quality systems. The Consultant position is essential for interpreting regulations, ensuring inspection readiness, and supporting continuous improvement related to the Right to Operate initiatives.
Benefits:
- Performance bonus once a year at the beginning of March
- Health insurance
- Life insurance
- 401k
- Short term and long term disability
- Sick time personal time
- Parental leave
Responsibilities:
- Strong commitment to Team Lilly principles.
- Participate in the creation/revision of global quality standards and perform gap assessments of local procedures.
- Support internal audits and external inspections; fulfill virtual inspection requests.
- Work with laboratory management to establish and report Quality metrics.
- Collaborate with QA and provide leadership for deviation triage meetings and Site Self Inspections.
- Participate in Deviation and Change Control Review Boards.
- Review and approve documents including, but not limited to, procedures, change controls, deviations, equipment qualifications, analytical methods, and computerized system validations.
- Provide coaching, feedback, and mentoring to QC personnel as it relates to the execution of quality systems.
- Contribute to and review Annual Product Reviews (APR), Quarterly Product and Process Self-Assessments (QPPA), laboratory periodic reviews, and equipment/computer system periodic reviews, as appropriate.
Qualifications:
- BS in Chemistry, Microbiology, or a science-related field.
- 5+ years of experience in the pharmaceutical/biopharmaceutical industry.
- 5+ years experience in QC in a GMP laboratory setting
- Strong knowledge of Quality systems
- Experience with audits, self-inspection, deviation and change management as well as Quality metrics
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Job Type: Full-time
Experience:
- pharmaceutical/biopharmaceutical industry: 5 years (Required)
- Quality Systems: 1 year (Preferred)
- compliance supporting quality control laboratory GMP area: 5 years (Required)
Education:
- Bachelor’s (Required)
Job distance:
- Branchburg, NJ: Between 31 and 40 miles (Preferred)