BioAgilytix · 10 hours ago
Data Reviewer (QC Specialist)
Triangle Area
Full-time
Onsite
Mid, Senior Level
2+ years expBioAgilytix is a company dedicated to providing premier bioanalytical services to support new medicine breakthroughs. The Data Reviewer (QC Specialist) will play a critical role in ensuring data integrity standards are met through technical reviews of raw and processed data, while also collaborating with scientific staff to uphold GxP compliance.
BiotechnologyLifestyle
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, 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
Qualification
Required
Bachelor's degree in biological science or related field, with between 2-10 years' experience working in biotech, pharmaceutical, CRO/CMO or similar organization; or Master's or PhD. with equivalent experience
Knowledge and/or extensive knowledge of GxP regulations
Two-Four (2-4) years' experience performing data review in a GxP environment
Experience with relevant bioanalytical methods such as immunoassays, cell-based assays, or qPCR
Self-motivated and demonstrated ability to learn and work in a fast-paced environment where multiple concurrent projects must be completed in a timely manner
Ability to perform your role independently with attention to detail and minimal oversight
Ability to perform technical review of data following GxP regulations and scientific principles
Expertise in communicating and building relationships with others, where all feel heard and respected
The confidence to make and share observations in a considerate manner
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
Company
BioAgilytix
BioAgilytix is a leading global contract research organization focused on supporting pharmaceutical and biotech partners in all phases of drug development.
1001-5000 employees
H1B Sponsorship
BioAgilytix has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (8)
2024 (8)
2023 (8)
2022 (6)
2021 (9)
2020 (4)
Funding
Current Stage
Late StageTotal Funding
unknown2016-02-22Acquired
Leadership Team
Davide Molho DVM
Chief Executive Officer
Maureen Marchek
Chief Financial Officer
Company data provided by crunchbase