Bioanalytical Data QC Specialist (GxP)

BioAgilytix Labs, LLC; Durham (NC); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Flexible Spending Account

Disability Insurance

Paid Time Off

Parental Leave

Paid Holidays

401k with Employer Match

Employee Referral Program

Job summary

BioAgilytix seeks a detail-oriented QC data reviewer to ensure data integrity across regulated studies (GLP/GMP). You will perform technical, scientific, and compliance reviews of data and documentation from the Bioanalytical Operations group, bridging lab and QA in a fast-paced environment.

You will identify deviations, OOS/OOT, collect QC metrics, and educate staff on best practices in GxP. This is not a bench role but leverages lab experience and strong regulatory know-how.

Qualifications

• Bachelor's degree in biological science with 2–10 years in biotech/pharma or related field
• Knowledge of GxP regulations
• 2–4 years' experience performing data review in a GxP environment
• Experience with immunoassays, cell-based assays, or qPCR

Responsibilities

• Perform QC technical, scientific, and compliance review of data and documentation generated by the Bioanalytical Operations group in support of regulated studies (e.g. GLP, GMP)
• Identify deviations, OOS and OOT associated with Bioanalytical Operations data as applicable
• Issue QC review observations and work closely with the scientific staff to ensure data integrity
• Collect metrics data used to monitor the QC reviews, and may identify process improvements
• Assist in educating, guiding and influencing the scientific staff in regard to best practices in GxP compliance

Skills

Self-motivated

Independent thinker

Attention to detail

Strong communication

Relationship building

GxP regulatory knowledge

Data review proficiency

LIMS knowledge

Education

Bachelor's degree in biological science

Master's degree or PhD with equivalent experience

Tools

LIMS

Quality Management software

Job description

BioAgilytix seeks a detail-oriented QC data reviewer to ensure data integrity across regulated studies (GLP/GMP). You will perform technical, scientific, and compliance reviews of data and documentation from the Bioanalytical Operations group, bridging lab and QA in a fast-paced environment.

You will identify deviations, OOS/OOT, collect QC metrics, and educate staff on best practices in GxP. This is not a bench role but leverages lab experience and strong regulatory know-how.