QC Analyst - Microbiology; Contractor- 2nd Shift

QC Analyst - Microbiology (Contractor)- 2nd Shift

Lexington, MA

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.

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.

The QC Analyst (contractor) will be responsible for routine and non-routine QC sampling and testing for the quality and safety of products manufactured for our clients. QC is responsible for execution of the Environmental Monitoring (EM) program to monitor Genezen's controlled manufacturing environment 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 holiday and occasional weekend operations. It may include in-process monitoring and testing, lot release testing, and stability testing.

Supporting activities for quality systems: utility monitoring excursions, non-conformance, deviations, corrective and preventive actions (CAPAs), investigations, Out of Specifications (OOS), and change controls may be required.

• Perform routine/non-routine environmental monitoring of cGMP environments.
• Perform routine/non-routine sampling of utility systems.
• Perform routine/non-routine testing and review of cGMP samples in accordance with Standard Operating Procedures (Bioburden, Endotoxin, TOC, Conductivity, Nitrate, Microbial Identification, Biological Indicator).
• Performs peer review with minimal errors.
• Perform laboratory tasks including general housekeeping, equipment monitoring and maintenance, inventory of supplies, etc.
• Assist with data trending and aid in compilation of trend reports.
• Support shipment of samples to contract testing laboratories, as required.
• Support of quality systems: utility monitoring excursions, non-conformance, deviations, corrective and preventive actions (CAPAs), investigations, Out of Specifications (OOS), and change controls.
• Maintain QC Microbiology related systems in compliance with industry standards.

Additional Requirements:

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

BA or BS in Microbiology or other related science.

Minimum 0-3 years of laboratory base experience within QC testing capacity, preferably in a cGMP environment.

Follow procedures trained on and complete documentation applying cGMP/GDP/ALCOA+.

Understanding of industry testing requirements/standards.

Proficiency in computer applications including MS Word, Excel, and LIMS (preferred).

Good/effective communication, organizational, and time management skills with the ability to work well with others and independently.

Flexibility and willingness to learn, with a proactive approach to making a positive impact.

Detail Oriented.

This is a temporary position paid through a third-party payrolling service. The hourly pay rate for the role is $32-$42/hr.

• Regularly sit for long periods of time.
• Frequently required to stand for extended periods of time and repetitive bending; sit; use hands to finger, handle, or feel; reach with hands and arms.
• Occasional…