Sr. QA Specialist (Fri-Sun 6am-6:30pm)

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 Senior Quality Assurance Specialist provides collaborative floor support, batch record review, and batch disposition. This role is accountable for all elements of the Quality Management System (QMS), including deviations, Corrective and Preventive Actions (CAPAs), excursions, Out of Specifications (OOS), change controls, and data integrity.

This role is aligned with the Manufacturing Friday-Sunday shift: Friday–Sunday, 6:00 AM–6:30 PM.

Responsibilities

• Oversee and provide regulatory compliance guidance during on-the-floor manufacturing activities.
• Support cGMP manufacturing operations through administration and enforcement of the Quality Management System, including deviations, change controls, and CAPAs.
• Review and approve documents from Manufacturing, such as SOPs, batch records, logbooks, and training forms.
• Perform Quality walkthroughs to maintain inspection readiness.
• Participate in batch disposition activities.
• Provide QA support for drug product aseptic fill operations and vial visual inspections.
• Assist in deviation investigations, CAPA, and Change Control implementations.
• Provide QA operation functional trainings, guidance, and mentorship to junior QA specialists.
• Support internal and external audits and inspections.
• Lead and support continuous improvement initiatives for Quality and production operations.

Requirements

• Adaptability required, as work schedule may change based on business needs.
• Criminal background check required.

Qualifications

• BS in science or engineering discipline.
• 8+ years of relevant GMP experience in a pharma/biotech company, working within a quality system and regulated GMP environment (desired).
• Experience working in a cGMP manufacturing environment (essential).
• Well-versed in cGMP, ICH, FDA, and EU regulations and guidelines (essential).
• Proficient in Microsoft applications (Outlook, Teams, Word, Excel, PowerPoint) (essential).
• Strong written and verbal communication skills for cross-functional teams (essential).
• Strong organizational skills (essential).
• High level of attention to detail (essential).
• Good problem-solving skills (essential).
• Capable of working with minimal supervision (essential).
• Ability to work well with diverse groups (essential).
• Ability to multi-task in a fast-paced environment with challenging timelines (essential).

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 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.

Company Values

• Committed to Science: We are committed to scientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare.
• Urgency in Action for the Patients: We operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners' programs.
• Resilience & Grit in Operations: We are committed to overcoming challenges, learning from failures, and persistently striving for success.
• Execute with Excellence & Integrity: We are dedicated to delivering quality results and upholding ethical principles.
• Solutions Driven for Our Partners: We are committed to being 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 and personal accident insurance.
• Voluntary disability, universal life, and personal accident insurance.
• Accidental Death & Dismemberment (AD&D) Insurance.

Pay

The anticipated annual salary range for the Senior QA Specialist is $100,000–$115,000, determined based on relevant experience, skills, and education.

Schedule

Friday–Sunday, 6:00 AM–6:30 PM.

Locations

Genezen operates in Fishers, Indiana (a suburb of Indianapolis) and Lexington, Massachusetts (northwest of Boston). Fishers was named the #1 place to live in the U.S. by Money Magazine in 2017 for its livability, safety, and entrepreneurship. Lexington is a historic suburb with rich cultural heritage, offering a blend of historical landmarks and modern amenities.