QC Analyst - Microbiology (Contractor)- 2nd Shift

JOB SUMMARY

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 in place to monitor Genezen's controlled manufacturing environments 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. This may include but is not limited to 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.

This position is a 2nd shift positions with a typical schedule of 1pm-9:30pm (4 days per week) and primary coverage for 4pm-12am (1 day per week) for a routine process. There will be the occasional later evening needed for unit ops support. 

ESSENTIAL JOB FUNCTIONS

• 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

KNOWLEDGE, SKILLS AND EXPERIENCE

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

PHYSICAL DEMANDS

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

Work Environment

• Regularly sit for long periods of time

Movement

• 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 


• 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


• 10 observed holidays + 2 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.