QC Analyst I - Sample Management

The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell therapy clinical trials and are proud to be a part of the process that leads to new cures.

WORKING AT GENEZEN

Many people have worked in environments where you feel like just another nameless part of an enormous machine. Genezen is different. We want our employees to be innovative, collaborative problem solvers who are dedicated to meeting the challenges of working at a fast-growing company. We are dedicated to empowering our employees to be their best and making Genezen a rewarding place to work. Every employee contributes to the success of the company and you can be part of that team.

JOB SUMMARY

The QC Sample Management Analyst I plays a critical role in supporting day-to-day quality operations within the cGMP QC laboratories. This role is responsible for overseeing all aspects of sample management, including the receipt, processing, storage, and retrieval of samples. The analyst will ensure compliance with documentation practices and contribute to maintaining an organized and efficient laboratory environment. This position is based at our state-of-the-art facility in Lexington, MA.

ESSENTIAL JOB FUNCTIONS

• Sample Management:
  • Ensure that all Manufacturing (MFG) and Pilot Plant samples received are accompanied by proper documentation, maintaining data integrity.
  • Dispense samples into aliquots and label them according to QC procedures.
  • Keep storage units accurately inventoried and organized.
  • Ensure all samples transferred in and out of storage units are correctly documented, adhering to good documentation practices (GDP).
  • Alert Quality Control management and project teams about samples received for protocols in the lab.
• Documentation and Compliance:
  • Organize and archive forms as needed, including scanning and filing documents.
  • Author and revise standard operating procedures (SOPs) as required.
  • Prepare release documentation for review and ensure compliance with assigned training.
  • Support internal and external audits as needed.
• Laboratory Support:
  • Perform general housekeeping tasks, monitor and maintain laboratory equipment, and manage inventory of supplies.
  • Prepare shipments for external testing and support continuous improvement initiatives to streamline lab processes.
• Additional Responsibilities:
  • Support data packet reconciliation and archival
  • Perform other related duties as assigned by the supervisor or QC management.

SPECIAL JOB REQUIREMENTS

• Adaptability required as work schedule may change based on business needs
• Criminal background check required
• Other duties as assigned

KNOWLEDGE, SKILLS AND EXPERIENCE

| EDUCATION / CERTIFICATIONS / LICENSES | Essential/Desired | | ------------------------------------------------------------------------------------------------------------------------------------------------------- | --------------------- | | Bachelor’s degree in Life Sciences | Desired | | ON-THE-JOB EXPERIENCE | | | 0-3 years of relevant GMP experience in a pharmaceutical/biotech company, with experience working within a quality system and regulated GMP environment | Desired | | SKILLS/ABILITIES | | | Experience with aseptic laboratory techniques | Essential | | Understanding of documentation practices related to cGMP and data integrity. | Desired | | Proficiency in computer applications including MS Word, Excel, and LIMS (preferred). | Desired | | Strong communication and organizational skills with the ability to work well with others and independently and as part of a team | Essential | | Flexibility and willingness to learn, with a proactive approach to making a positive impact | Desired |

PHYSICAL DEMANDS

While performing the duties of this job, the employee is required to meet the following 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; high, precarious places; toxic or caustic chemicals; hazardous waste; and risk of electrical shock
• Occasionally exposed to extremely loud noise levels

Movement

• Frequently required to stand; sit; walk; balance; stoop; kneel; crouch; use hands to finger, handle, or feel; reach with hands and arms
• Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl

Lifting

• Frequently lift and/or move up to 25 pounds
• Occasionally lift and/or move up to 50 pounds

Vision

• Frequently utilize close vision and the ability to adjust focus
  Communication
• Frequently required to communicate by talking, hearing, using telephone and e-mail

GENEZEN'S CURES VALUE-BASED COMPETENCIES

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 principals.

Solutions driven for our partners
We are committed to being a proactive, collaborative, creative and open-minded partner.

GENEZEN'S BENEFITS

• Paid vacation days, amount based on tenure
• Paid sick time
• 9 observed holidays + 1 floating holiday + 1 volunteer day
• 401(k) plan with company match up to 6% of salary, vested immediately
• 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

ADDITIONAL DETAILS

• Nothing in the job description for this role restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
• This position requires a criminal background check.
• Genezen is an Equal Opportunity Employer.
• Genezen participates in EVerify.
• Genezen is interested in every qualified candidate who is eligible to work in the United States; however, we are not able to sponsor visas.

Genezen has operates two locations: one in Fishers, Indiana and the second in Lexington, Massachusetts.

Fishers is a suburb of Indianapolis. Fishers was 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 and is dedicated to supporting a high quality of life for all its residents. Nearby Indianapolis is home to professional and college sports teams, the Indy 500, a growing art community and the world’s largest children’s museum--to name just a few reasons why this area is a great place to live.

Lexington, Massachusetts, located just northwest of Boston, is renowned as a historic suburb with a rich cultural heritage. It boasts picturesque New England charm, tree-lined streets, and a vibrant community. Known for its pivotal role in the American Revolution, Lexington offers visitors and residents alike a blend of historical landmarks, modern amenities, and a strong sense of community pride.