Quality Assurance Analyst II

1 week ago

Lexington, Kentucky, United States Genezen Full time
Job Overview

The realm of gene therapy is advancing swiftly, and Genezen is poised to address the precise requirements of our clientele. We specialize in process development, manufacture GMP viral vectors, and facilitate cell transduction for gene and cell therapy clinical trials, proudly contributing to the emergence of innovative 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 inventive, collaborative problem solvers committed to tackling the challenges inherent in a rapidly expanding organization. We are devoted to empowering our workforce to excel and making Genezen a fulfilling place to work. Every team member plays a vital role in the company's success, and you can be part of that journey.

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 authorize batch records, solution lot records, and raw material release documentation.
  • Assist in internal and external audits.
  • Examine, support investigations of, 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 other assigned duties as necessary.

QUALIFICATIONS AND SKILLS

  • A minimum of a Bachelor's degree in Life Sciences or Engineering.
  • 2-6 years of relevant GMP experience in a pharmaceutical or biotechnology setting, operating within a quality system and regulated GMP environment.
  • Thorough understanding 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 capability to gown aseptically.

PHYSICAL REQUIREMENTS

While performing the duties of this position, the employee is expected to meet the following physical demands:

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

MOVEMENT

  • Frequently required to stand, sit, use hands for handling or feeling, and reach with hands and arms.
  • Occasionally required to walk, climb, balance, stoop, kneel, crouch, or crawl.

LIFTING

  • Frequently lift and/or move up to 10 pounds.
  • Occasionally lift and/or move up to 25 pounds.

VISION

  • Frequently utilize close vision and the ability to adjust focus.

COMMUNICATION

  • Frequently required to communicate verbally and through written means, including telephone and email.

GENEZEN'S CORE VALUES

Committed to Science: We uphold scientific excellence, remain informed on industry advancements, make data-driven decisions, and pursue innovation to enhance healthcare.

Urgency in Action: We act with urgency and dedication to delivering timely treatments to patients by expediting our partners' programs.

Resilience & Grit: We are dedicated to overcoming obstacles, learning from setbacks, and persistently striving for success.

Execute with Excellence & Integrity: We are committed to delivering quality outcomes while adhering to ethical principles.

Solutions Driven: We strive to be proactive, collaborative, creative, and open-minded partners.

GENEZEN'S BENEFITS

  • Paid vacation days, determined by 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.
  • This position requires a criminal background check.
  • Genezen is an Equal Opportunity Employer.
  • Genezen participates in E-Verify.
  • Genezen welcomes all qualified candidates eligible to work in the United States; however, we are unable to sponsor visas.

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