Cognate: QC Analyst I-BioAssay

The Fountain Group; Memphis (TN); On-site; USD 60,601,000 - 70,202,000; Full time

Job summary

The Fountain Group seeks a QC Bioassay Analyst I/II in Memphis, TN for a 4-month assignment. You will perform immunoassays, mammalian cell culture, and molecular assays under cGMP/GLP, ensuring data integrity and precise reporting.

You will review results, trend data, and participate in investigations while maintaining documentation per SOPs and GDP guidelines.

Qualifications

• Bachelor’s degree in Biological Sciences or related field is preferred.
• 1–2 years in a lab, biotech, cell therapy, or related industry desirable.
• Experience with cell-based immunoassays and GMP documentation is valued.

Responsibilities

• Perform QC testing using cell-based immunoassays (MLR, cytotoxicity, CTLp).
• Culture mammalian cells with aseptic technique and established SOPs.
• Execute molecular biology-based assays per approved methods.
• Review QC results for accuracy and compliance.
• Design studies, analyze data, and prepare reports.
• Enter observations into trending databases and support data trends.
• Maintain lab inventories and records; support CAPA and investigations.
• Adhere to cGMP/GLP and GDP to ensure data integrity.

Skills

Cell-based immuno assays

Mammalian cell culture

Aseptic technique

Cell proliferation assays

Cytotoxicity assays

MLR assays

HLA restriction assays

CTLp assays

Molecular biology assays

cGMP compliance

GLP

GDP practices

SOP compliance

QC testing

OOS investigations

CAPA

Data traceability

Statistical analysis

QC trending

Education

Bachelor’s degree in Biological Sciences

Job description

Job Title: QC Bioassay Analyst I/II
Location: Memphis, TN
Pay Rate: $21.13–$24.50/hr.
Duration: 4 months
Schedule: Monday–Friday, 8:00 AM–4:30 PM; overtime as needed
Training: 1 month, Monday–Friday, 8:00 AM–5:00 PM

Job Description

• Perform QC testing using cell-based immunological in vitro assays, including MLR, cytotoxicity, HLA-restriction, CTLp, and cell proliferation assays.
• Perform mammalian cell culture using aseptic techniques and established cell culture procedures.
• Execute molecular biology-based assays and laboratory testing according to approved methods and SOPs.
• Review QC test results for accuracy, precision, and compliance with established requirements.
• Perform study design, data analysis, statistical analysis, and preparation of written and oral test reports.
• Enter test observations and results into trending databases and support periodic data trending.
• Maintain QC laboratory inventories, testing logs, documentation, and records.
• Support laboratory investigations, including OOS and CAPA activities.
• Follow cGMP/GLP requirements, SOPs, and Good Documentation Practices to maintain data integrity and traceability.

Education

• Bachelor’s degree in Biological Sciences or a related field preferred.
• 1–2 years of applicable laboratory, biotechnology, cell therapy, or related industry experience, or an equivalent combination of education and related work experience.

Required Skills

• Cell-based immunological in vitro assays
• Mammalian cell culture
• Aseptic technique
• Cell proliferation assays
• Cytotoxicity assays
• MLR (Mixed Lymphocyte Reaction)
• HLA-restriction assays
• CTLp assays
• Molecular biology-based assays
• cGMP / 21 CFR 210 and 211
• GLP
• Good Documentation Practices (GDP)
• SOP compliance
• QC testing and results review
• OOS investigations
• CAPA
• Data integrity and traceability
• Statistical/data analysis
• QC data trending

Preferred Skills

• Biotech or cell therapy laboratory experience
• QC laboratory operations
• Experience with trending databases
• Laboratory documentation and product release testing
• Experience supporting quality improvement initiatives