QC Technician - Microbiology (Contract)

Job Description

Job Description

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 Technician contract role will be responsible for routine and non-routine QC sampling and testing for the quality of products manufactured for our clients. QC is responsible for execution of the Environmental Monitoring (EM) program in place to monitor Genezen's controlled manufacturing environments (cleanrooms) as well as monitoring of utility systems including Water for Injection (WFI), Pure Steam, Purified Water, Compressed Air and Gas systems. These activities are all performed in accordance with cGMP guidelines and are supported by departmental and inter­departmental policies and standard operating procedures (SOPs). This position is based at Genezen's state-of-the-art facility in Lexington, MA. This role supports daily operations as well as occasional weekend and holiday operations. T

ESSENTIAL JOB FUNCTIONS

• Perform routine and non-routine Environmental Monitoring (EM) of controlled GMP environments.
• Perform routine and non-routine sampling of utility systems.
• Perform Manufacturing process EM.
• Perform data entry and review raw data.
• Perform operational laboratory tasks including general housekeeping, equipment monitoring and maintenance, inventory of supplies, etc.
• Sampling and testing of process and compressed air systems supporting Manufacturing.
• Completion of documentation in accordance with cGMP and ALCOA principles.
• Support internal and external audits, as required.
• Generate / support continuous improvement to streamline lab and processes.
• Maintain compliance with assigned training.
• Support other QC functional groups, as assigned.
• Support holiday and weekend coverage, as required.
• 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

HS degree with Biotechnology Certificate / Associate or Bachelor's degree in Microbiology or other related science

Essential

ON-THE-JOB EXPERIENCE

Minimum 0-2 years of laboratory based experience within QC testing capacity, preferably in cGMP environment.

Essential

Experience performing Environmental and Utility monitoring

Desired

Experience in aseptic laboratory technique and aseptic gowning

Desired

SKILLS / ABILITIES

Understanding of documentation practices related to cGMP and ALCOA

Desired

Computer literacy (MS Word, Excel, LIMS), good communication and organizational skills are required

Essential

Flexible team player with effective communication and organizational skills with the ability to work well with others and independently

Essential

Proficient learner with desire to make a difference

Essential

PHYSICAL DEMANDS

While performing the duties of this job, the employee is required to meet the following physical demands :

Work Environment

Movement

Lifting

Vision

Communication

GENEZEN'S CURES VALUE-BASED COMPETENCIES

C ommitted to Science

We are committed to scientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare.

U rgency in action for the patients

We operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners' programs.

R esilience & Grit in operations

We are committed to overcoming challenges, learning from failures, and persistently striving for success.

E xecute with Excellence & Integrity

We are dedicated to delivering quality results and upholding ethical principals.

S olutions driven for our partners

We are committed to being a proactive, collaborative, creative and open-minded partner.

GENEZEN'S BENEFITS

ADDITIONAL DETAILS

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.