JobJob Title:

QC Analyst - Bioassay /

Analytical Testing Contract:

6

Months Location:

Onsite Schedule:

Wednesday-Saturday, 7:00 AM-5:30

PM Training:

First 7 weeks, Monday-Friday, 7:30 AM-4:00 PM Job Summary We are seeking a QC Analyst to support analytical testing and quality control activities within a GMP biopharmaceutical manufacturing environment. The ideal candidate will have hands-on experience with analytical techniques such as Flow Cytometry, ELISA, qPCR/PCR, and cell-based bioassays , along with knowledge of GMP and quality systems. Responsibilities Perform testing of raw materials, intermediates, and final products using cell-based bioassays, Flow Cytometry, ELISA, and qPCR/PCR . Review and trend laboratory data and testing documentation. Support in-process testing and drug substance/drug product release activities. Provide information to support generation of Certificates of Analysis (CoAs). Maintain laboratory instruments, including calibration and routine maintenance. Author and revise SOPs, qualification/validation protocols, and reports . Assist with OOS investigations , deviations, and root-cause analysis. Monitor GMP systems and ensure compliance with established procedures. Review proposed changes to systems, procedures, and analytical methods as appropriate. Gather metrics to support continuous improvement initiatives. Participate in daily and weekly team meetings and provide status updates. Perform other duties as assigned. Basic Qualifications Bachelor's degree , OR Associate/AA degree with 2+ years of experience in biotechnology or a related field and Quality Control experience, OR High School diploma with 3+ years of experience in biotechnology or a related field and Quality Control experience. Preferred Qualifications Hands-on experience with Flow Cytometry, ELISA, PCR/qPCR, and cell-based bioassays . Strong knowledge of GMP, SOPs, and QC processes . Experience identifying, documenting, investigating, and closing OOS results and deviations . Knowledge of 21 CFR Part 11, 210, and 211 . Experience in the biotechnology or pharmaceutical industry . Strong written and verbal communication skills. Proficiency with MS Word, Excel, PowerPoint , and related applications. Ability to work independently and collaborate effectively with scientific and technical teams. Schedule Requirements The position is onsite . For the first 7 weeks , all contractors must work: Monday-Friday | 7:30 AM-4:00 PM This period is required for New Hire Orientation and Manufacturing Onboarding Technical Training. After successful completion of training, the contractor will transition to the agreed-upon shift: Wednesday-Saturday | 7:00 AM-5:30

PM Contract Duration:

6 Months SNR8 #IND2

Pay:

$25.00 - $29.85 per hour

Benefits:

401(k) Dental insurance Health insurance Vision insurance Application Question(s):

• Are you a US Citizen or GCH? If on Visa please mention the Visa Status
• Are you ready for background check and drug screen in accordance with the local law and regulations?
• Please confirm your email address and contact number?
• Cube Hub payroll is "Bi-Weekly, we pay every-other-Friday. Are you Comfortable with Bi-Weekly payroll policy?
• What is your Expected Pay Range?
• What is a good time to contact you?
• Are you ok with following Shift (First Shift) Do you have hands-on experience with Flow Cytometry, ELISA, qPCR/PCR, or cell-based bioassays?

Do you have experience testing raw materials, intermediates, and/or final products in a GMP pharmaceutical/biotech environment? Do you have hands-on experience with OOS investigations, deviations, root-cause analysis, and GMP documentation? (Y/N)

Work Location:

In person