Data Review (QC Specialist) 6-Mo Contract

About the role

At BioAgilytix, we deliver tailored bioanalytical services that support new medicine breakthroughs. Our fast-paced, solution-oriented culture offers rapid career development and exposure to diverse drug modalities. In this role, you will ensure data integrity by performing technical reviews of raw and processed data across various equipment, regulatory settings, and workflows. You’ll act as a bridge between the lab and the quality assurance team, applying regulatory knowledge to plate-based assays, cell work, gene therapy, and more. Ideal candidates thrive in deadline-driven environments and are passionate about delivering high-caliber data to enable life-changing therapeutics.

Responsibilities

• Perform Quality Control (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, out-of-specification (OOS), and out-of-trend (OOT) results associated with Bioanalytical Operations data.
• Issue QC review observations and collaborate with scientific staff to ensure data integrity.
• Collect metrics data to monitor QC reviews and identify process improvements.
• Assist in educating, guiding, and influencing scientific staff on best practices in GxP compliance.

Requirements

• Bachelor’s degree in biological science or related field, with 2–10 years’ experience in biotech, pharmaceutical, CRO/CMO, or similar organization; or Master’s/PhD with equivalent experience.
• Knowledge of GxP regulations, with 2–4 years’ experience performing data review in a GxP environment.
• Experience with bioanalytical methods such as immunoassays, cell-based assays, or qPCR.

Skills

• Self-motivated with the ability to work independently in a fast-paced environment with minimal oversight.
• Strong attention to detail and expertise in technical data review following GxP regulations and scientific principles.
• Excellent communication and relationship-building skills, fostering an environment where all feel heard and respected.
• Confidence in making and sharing observations considerately.
• Proficiency in LIMS and Quality Management software packages.

Benefits

• Medical Insurance (HDHP with HSA; PPO), Dental Insurance, Vision Insurance.
• Flexible Spending Account (medical; dependent care).
• Short-Term Disability, Long-Term Disability, Life Insurance.
• Paid Time Off (4 weeks per year), Parental Leave, Paid Holidays (9 scheduled; 5 floating).
• 401k with Employer Match, Employee Referral Program.