QC Analyst - Bioassay Temp - 2nd Shift (1-9:30pm)

The QC Analyst temporary role will be responsible for routine and non-routine QC testing within the Bioassay team within a GMP laboratory.  This is a 2^nd shift, full on-site, position (1 – 9.30pm) 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 training period will be on first shift. All activities are all performed in accordance with cGMP guidelines and are supported by departmental and inter-departmental policies and standard operating procedures. 

• 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. 

• 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).
• Other duties as assigned.

 

BA/BS in Biochemistry/Cell Biology or other related science

Essential

Minimum 2 years’ laboratory base experience within QC testing capacity, preferably in cGMP environment.

Essential

High proficiency in cell culture and cell-based assays

Essential

Understanding of industry testing requirements/standards

Essential

 

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

Essential

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

Essential

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

Essential

Detail Oriented

Essential

 

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

Work Environment

• Frequently required to work in a BSL 2 environment with personal protective equipment/aseptic gowning
• Regularly required to work around large machinery and typical utilities seen in pharmaceutical facilities
• Occasionally exposed to moving mechanical parts; high, precarious places; toxic or caustic chemicals; hazardous waste; and risk of electrical shock
• Occasionally exposed to extremely loud noise levels

Movement

• Frequently required to stand; sit; walk; balance; stoop; kneel; crouch; 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

 

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.

• 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.