QC Analyst - Microbiology (Temporary, 2nd shift, Sat-Mon, 12pm-12:30am)

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 Analyst contractor will be responsible for routine and non-routine QC sampling and testing of controlled environments, critical utility systems, and production processes operating in a GMP laboratory. This position works a 2nd shift 12-hour schedule, Saturday-Monday,12-pm-12:30am, fully on-site schedule with occasional holiday support required.

QC Microbiology is responsible for the Environmental Monitoring (EM) program as well as utility monitoring programs, 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. The role supports routine operations of a 7-day production schedule. This may include but is not limited to in-process monitoring and testing activities for utility, intermediates, raw materials and drug product samples. The role also supports quality management systems, including; utility monitoring excursions, non-conformance, deviation investigations, corrective and preventive actions (CAPAs), Out of Specifications (OOS), and change controls, as required.

ESSENTIAL JOB FUNCTIONS

Perform QC testing of in-process and product samples while adhering to standard operating procedures (SOPs).

Ensure routine QC Environmental Monitoring and Microbiology sampling/testing such as bioburden, endotoxin, growth promotion, Gram stain, and microbial identifications, are performed in compliance with all industry regulations and standards.

Write, revise, or review SOPs for quality control operations to assure regulatory requirements and industry standards are met.

Support aseptic processing activities.

Complete documentation, perform data entry and review in accordance with Good Manufacturing Practices (cGMP) applying ALCOA+

Perform laboratory tasks including general housekeeping, equipment monitoring and maintenance, inventory of supplies, etc.

Sampling and testing of critical utility systems including water and gas supplied to manufacturing areas.

Perform data trending and aid in compilation of trend reports.

Prepare samples for shipment to contract testing laboratories and review of testing data reports, as required.

Conduct non-conformance and Out of Specification and laboratory investigations and environmental monitoring excursion investigations

Troubleshooting equipment and microbiological testing methods.

Training of other Analysts within the department within scope of knowledge.

Support internal and cross-functional project related activities as needed.

SPECIAL JOB REQUIREMENTS

Adaptability required as work schedule may change based on business needs.

Work outside of normal business hours, including nights, weekends and holidays, when necessary.

Criminal background check required (completion by staffing agency satisfies this requirement).

Other duties as assigned.

KNOWLEDGE, SKILLS AND EXPERIENCE

EDUCATION / CERTIFICATIONS / LICENSES

Essential/Desired

A minimum of a Bachelor’s degree in Life Science or related science

Essential

ON-THE-JOB EXPERIENCE

3+ Years of QC Microbiology Experience

Essential

SKILLS / ABILITIES

Strong understanding of required laboratory practices including aseptic technique

Essential

Well versed in cGMP/ICH/FDA/EU regulations and guidelines

Essential

Proficient in using Microsoft applications (MS Word, MS Excel, MS PowerPoint)

Essential

Must be able to demonstrate ability to gown aseptically

Essential

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

Essential

PAY RATE:

This position is being filled through a third-party staffing agency and is a temporary assignment. The anticipated hourly pay range for this position is $30 - $45 per hour, based on qualifications, skills, experience, and other job-related factors.

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; 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 10 pounds

Rarely lift and/or move up to 25 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

• 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

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

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 wit