QC Analyst - Microbiology (Temporary, 1st shift, Fri-Sun 6am-6:30pm)

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 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 first shift, 12-hour schedule, Friday-Sunday, 6am-6:30pm 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 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.