QC Analyst - Bioassay (Temporary, 2nd shift, Wed-Sat)

Job Summary

The QC Analyst will be responsible for routine and non-routine QC testing within the Bioassay team within a GMP laboratory. This is a 2nd shift, Wednesday-Saturday, fully on-site, position (1 – 11.30pm) based at Genezen’s new state-of-the-art facility in Lexington, MA. This role supports daily operations within the Quality Control group through execution of cell-based testing, routine lab support and working within Quality Systems. This includes but is not limited to in-process testing, lot release testing, and stability testing. Support outside of standard shift hours is required occasionally and the initial work period will be on Mon-Fri. All activities are executed in accordance with cGMP guidelines and are supported by departmental and inter-departmental policies and standard operating procedures.

Essential Job Functions

• Perform routine/non-routine cell-based testing and review of in-process, DS and DP release and stability samples in accordance with Standard Operating Procedures (q-PCR, ddPCR, cell culture, ELISA)
• Perform peer review as SME of assay data with minimal errors
• Participate in equipment validation, method transfer/qualification/validation, critical reagent qualification and special protocol execution as required
• Review/generate protocols and reports, as required
• Establish, revise, review and maintain standard operating procedures
• Promptly and proactively communicates gaps to leadership
• Work as an active member of internal/cross-functional teams
• Train other analysts, as required

Special Job Requirements

• Strong understanding of GxP regulations, ability to apply to any situation, and identify deficiencies w/ some guidance
• Adaptability required as work schedule may change based on business needs
• Criminal background check required (completion by staffing agency satisfies this requirement)

Knowledge, Skills and Experience

• Educational Requirements: BA/BS in Biochemistry/Cell Biology or other related science
• On-the-Job Experience: Minimum 2 years’ laboratory base experience within QC testing capacity, preferably in cGMP environment
• Skills: Thorough understanding of industry testing requirements/standards, computer literacy (MS Word, Excel, and LIMS), good/effective communication and organizational skills with the ability to work well with others and independently

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 - $40 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 armsOccasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl Lifting Frequently lift and/or move up to 10 poundsRarely 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

• Committed to Science
• Urgency in action for the patients
• Resilience & Grit in operations
• Execute with Excellence & Integrity
• Solutions driven for our partners

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.
• 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.