Quality Assurance Analyst II

2 weeks ago

Lexington, Kentucky, United States Genezen Full time
Job Overview

The field of gene therapy is expanding swiftly, and Genezen is committed to fulfilling the precise requirements of our clients. We specialize in process development, the production of GMP viral vectors, and cell transduction for gene and cell therapy clinical trials, playing a vital role in the journey towards new cures.

WORKING AT GENEZEN

Many individuals have experienced workplaces where they feel like just another faceless component of a vast machine. Genezen stands apart. We seek employees who are innovative, collaborative problem solvers, dedicated to tackling the challenges of a rapidly growing organization. We empower our staff to excel and strive to make Genezen a fulfilling place to work. Every team member plays a crucial role in the company's success, and you can be a part of that mission.

ROLE PURPOSE

The Quality Assurance Specialist II is responsible for supporting daily quality operations through active presence in the Manufacturing Clean Room, overseeing Material/Inventory QA Release, and managing all aspects of the Quality Management System (QMS). This includes, but is not limited to, handling deviations, Corrective and Preventive Actions (CAPAs), change control, batch review, data integrity, and training in support of biologics manufacturing production.

KEY RESPONSIBILITIES

  • Facilitate cGMP manufacturing and supply chain operations by administering and enforcing the Quality Management System, including deviations, change controls, and CAPAs.
  • Review and approve batch records, solution lot records, and raw material release documentation.
  • Assist in internal and external audits.
  • Investigate and approve deviations related to supply chain and production processes.
  • Provide on-site QA support for production and supply chain activities.
  • Represent Quality Assurance in project teams and meetings.
  • Identify and implement enhancements to Quality Management System procedures to drive positive change with minimal supervision.
  • Perform additional duties as assigned.

QUALIFICATIONS AND SKILLS

  • A Bachelor's degree in Life Sciences or Engineering is required.
  • 2-6 years of relevant GMP experience in a pharmaceutical or biotechnology setting, working within a quality system and regulated GMP environment.
  • Strong knowledge of cGMP/ICH/FDA/EU regulations and guidelines.
  • Proficient in Microsoft Office applications (MS Word, MS Excel, MS PowerPoint).
  • Ability to lift 25 pounds and demonstrate aseptic gowning capability.

PHYSICAL REQUIREMENTS

While performing the duties of this role, the employee must meet the following physical demands:

  • Occasional exposure to high noise levels.
  • Work may involve a combination of remote and on-site responsibilities.
  • Regularly sit for extended periods.

GENEZEN'S CORE VALUES

Committed to Science: We prioritize scientific excellence, staying updated with 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 strive to be proactive, collaborative, creative, and open-minded partners.

GENEZEN'S BENEFITS

  • Paid vacation days based on tenure.
  • Paid sick leave.
  • 9 observed holidays plus 1 floating holiday and 1 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.
  • Voluntary 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.
  • A criminal background check is required for this position.
  • 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.

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