QA Specialist II (M-F 3:00pm-11:30pm)

About the Company

Genezen provides process development, GMP viral vector production, and cell transduction for gene and cell therapy clinical trials. We are dedicated to empowering employees to be innovative, collaborative problem solvers in a fast-growing company where every team member contributes to success.

About the Role

In support of biologics and gene therapy manufacturing operations, the Quality Assurance Specialist II provides collaborative floor support and batch record review to ensure timely and compliant batch disposition. This role is accountable for all elements of the Quality Management System (QMS), including deviations, Corrective and Preventive Actions (CAPAs), change controls, and data integrity. The position is aligned with Manufacturing 2nd shift, Monday-Friday, 3pm-11:30pm.

Responsibilities

• Oversee and provide compliance guidance during on-the-floor manufacturing activities.
• Work alongside manufacturing teams to ensure current and best practices are implemented.
• Support cGMP manufacturing operations through administration and enforcement of the Quality Management System, including deviations, change controls, and CAPAs.
• Review and approve executed batch records, solution lot records, and logbooks.
• Participate in batch disposition activities.
• Provide QA support for drug product aseptic fill operations and vial visual inspections.
• Assist in deviation investigations.
• Support internal and external audits and inspections.
• Contribute to continuous improvements.
• Adapt to schedule changes based on business needs.

Requirements

• BS in science or engineering discipline.
• 3-5 years of relevant GMP experience in a pharma/biotech company, working within a quality system and regulated GMP environment.
• Experience working in a cGMP manufacturing environment.
• Well-versed in cGMP, ICH, FDA, and EU regulations and guidelines.
• Criminal background check required.

Skills

• Proficient in Microsoft applications (Outlook, Teams, Word, Excel, PowerPoint).
• Strong written and verbal communication skills for cross-functional teams.
• Strong organizational skills.
• High level of attention to detail.
• Good problem-solving skills.
• Capable of working with minimal supervision.
• Ability to work well with diverse groups.
• Ability to multi-task in a fast-paced environment with challenging timelines.

Competencies

• Committed to Science: Dedicated to scientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation.
• Urgency in Action for the Patients: Operate with urgency and commitment to delivering timely treatments to patients by accelerating partners' programs.
• Resilience & Grit in Operations: Overcome challenges, learn from failures, and persistently strive for success.
• Execute with Excellence & Integrity: Deliver quality results and uphold ethical principles.
• Solutions Driven for Our Partners: Be a proactive, collaborative, creative, and open-minded partner.

Benefits

• Paid vacation days (amount based on tenure).
• Paid sick time.
• 10 observed holidays + 2 floating holidays + 1 volunteer day.
• 401(k) plan with company match up to 6% of salary.
• Share Appreciation Rights.
• Choice of several healthcare plans.
• FSA and HSA programs.
• Dental & vision care.
• Employer-paid basic term life/personal accident insurance.
• Voluntary disability, universal life/personal accident insurance.
• Accidental Death & Dismemberment (AD&D) Insurance.

Pay

The anticipated annual salary range for the QA Analyst II is $80,000-$95,000, determined based on relevant experience, skills, and education.

Schedule

Monday-Friday, 3pm-11:30pm.

Physical Demands

• Work Environment:
  • Frequently required to work in a BSL 2 environment with personal protective equipment/aseptic gowning.
  • Regularly required to work around large machinery and typical utilities seen in pharmaceutical facilities.
  • Occasionally exposed to moving mechanical parts, caustic chemicals, and hazardous waste.
  • Occasionally exposed to loud noise levels.
  • Spending time on the floor during activity execution (maintenance, construction, commissioning, and qualification) is required.
• Movement:
  • Frequently required to stand and sit.
  • Occasionally required to walk, climb or balance, and stoop/crouch.
• Vision: Frequently utilize close vision and the ability to adjust focus.
• Communication: Frequently required to communicate by talking, hearing, using telephone, and email.

Locations

Genezen operates in two locations:

• Fishers, Indiana: A suburb of Indianapolis, named the #1 place to live in the US by Money Magazine in 2017 for its livability, safety, and entrepreneurship. Fishers is one of the fastest-growing communities in Indiana, offering a high quality of life. Nearby Indianapolis features professional and college sports teams, the Indy 500, a growing art community, and the world’s largest children’s museum.
• Lexington, Massachusetts: Located just northwest of Boston, known for its historic charm, tree-lined streets, and vibrant community. Lexington offers a blend of historical landmarks, modern amenities, and a strong sense of community pride.