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Supply Chain Quality Assurance Specialist II

2 months ago

Lexington, Kentucky, United States Genezen Full time
Job Overview

The field of gene therapy is expanding rapidly, and Genezen is committed to fulfilling the precise requirements of our clients. We specialize in process development, manufacture GMP viral vectors, and facilitate cell transduction for gene and cell therapy clinical trials, proudly contributing to the journey towards innovative cures.

WORKING AT GENEZEN

Many individuals have experienced workplaces where they feel like just another anonymous cog in a vast machine. Genezen stands apart. We seek employees who are innovative, collaborative problem solvers dedicated to tackling the challenges of a fast-growing organization. We empower our team members to excel and strive to make Genezen a fulfilling place to work. Every employee plays a vital role in the company's success, and you can be part of that journey.

ROLE PURPOSE

The Supply Chain Compliance Associate will be an integral member of a cohesive team tasked with managing Deviation investigations, CAPAs, and Change Controls within the Supply Chain. This role requires a deep understanding of cGMP regulations and project management skills to ensure compliance and error-proofing. The incumbent will also contribute to documentation and operational improvement initiatives within the Supply Chain, working independently with minimal supervision.

KEY RESPONSIBILITIES

  • Leverage Supply Chain expertise and investigative skills to identify and rectify issues, enhance process operations, and drive positive change.
  • Conduct root cause analyses on Supply Chain quality incidents and lead investigations for both minor and major quality events.
  • Identify and implement corrective and/or preventative actions within the Supply Chain.
  • Participate in Change Control Review Meetings to address and resolve inquiries related to changes, preparing assessments on change controls affecting Supply Chain.
  • Engage in cross-functional Vendor Change Notification teams to facilitate material changes or enhancements.
  • Assist in managing Supplier Corrective Action Requests.
  • Support document revisions and management, including Standard Operating Procedures and Label Specifications.
  • Assist during Regulatory Agency inspections.
  • Exemplify current good manufacturing practices, adhere to standard operating procedures, and maintain compliant documentation.
  • Perform tasks that consistently require independent decision-making and the exercise of judgment, with periodic management guidance.
  • Generate and present trending and metrics reports.
  • Demonstrate adaptability as work schedules may shift based on business needs.
  • Other responsibilities as assigned.

EDUCATION AND CERTIFICATIONS

Preferred/Required

Bachelor's degree in Supply Chain or a related scientific field.

EXPERIENCE

Minimum of 2-3 years of relevant industry experience in a related field.

Experience in managing investigations and writing deviations, executing CAPAs, and overseeing Change controls is essential.

Experience in performing root cause analysis using methodologies such as Event & Causal Factor Charting, Kepner-Tregoe Problem Analysis, and basic Quality Improvement Tools (e.g., Pareto Chart, Control Chart, Process Map, etc.) is preferred.

Ability to comply with internal company policies and regulatory standards (EMA, FDA) is essential.

SKILLS AND ABILITIES

Ability to apply systems thinking in problem-solving.

Demonstrates empathy in industrial contexts when collaborating with stakeholders.

Detail-oriented with strong self-organization skills.

Capable of professional communication across diverse levels and channels.

Proactive in taking ownership and resolving issues.

Strong technical writing and verbal communication skills.

PHYSICAL REQUIREMENTS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

GENEZEN'S CORE VALUES

Committed to Science: We prioritize scientific excellence, staying informed about industry advancements, making data-driven decisions, and pursuing innovation to enhance healthcare.

Urgency for Patients: We act with urgency and a commitment to delivering timely treatments to patients by accelerating our partners' programs.

Resilience in Operations: We are dedicated to overcoming challenges, learning from setbacks, and persistently striving for success.

Excellence and Integrity: We are committed to delivering quality results while upholding ethical principles.

Solutions-Oriented: We aim to be proactive, collaborative, creative, and open-minded partners.

GENEZEN'S BENEFITS

  • Paid vacation days, determined by tenure.
  • Paid sick leave.
  • Nine observed holidays plus one floating holiday and one volunteer day.
  • 401(k) plan with company match up to 6% of salary, vested immediately.
  • Share Appreciation Rights.
  • Choice of multiple healthcare plans.
  • Flexible Spending Account (FSA) and Health Savings Account (HSA) options.
  • Dental and vision coverage.
  • Employer-paid basic term life and personal accident insurance.
  • Optional disability and universal life/personal accident insurance.
  • Accidental Death & Dismemberment (AD&D) Insurance.

ADDITIONAL INFORMATION

  • This job description does not restrict management's right to assign or reassign duties and responsibilities at any time.
  • This position requires a criminal background check.
  • Genezen is an Equal Opportunity Employer.
  • Genezen participates in EVerify.
  • Genezen welcomes all qualified candidates eligible to work in the United States; however, we are unable to sponsor visas.