Quality Control Data Reviewer I
About The Position
Perform comprehensive quality review of bioanalytical assay data for accuracy, completeness, data integrity, and compliance with GLP/GCP requirements, study protocols, SOPs, and client expectations. Review datasets generated from method development, method validation, and sample analysis studies. Review study reports, protocols, protocol amendments, and supporting documentation for accuracy and compliance. Review sample management documentation and verify samples are appropriately documented and stored in LIMS. Review laboratory equipment calibration records, logbooks, and other quality documentation. Ensure laboratory records and documentation accurately reflect actual laboratory activities and events. Work closely with analysts and scientific staff to investigate and resolve data discrepancies, sample management questions, and documentation issues. Maintain accurate QC review records in accordance with SOPs and quality best practices. Initiate and coordinate quality events in TrackWise with Lead Scientists. Communicate with management and internal departments regarding data review findings and study status. Support the development and revision of SOPs, work instructions, methods, study plans, and training materials. Assist with training and mentoring team members as appropriate to experience level and qualification. Track QC metrics, identify recurring errors or trends, and contribute to continuous improvement initiatives that enhance quality and efficiency. Support internal and external audits and maintain awareness of applicable regulatory requirements and industry best practices. Complete required training within established timelines and maintain compliance with laboratory safety policies.
Requirements
- Bachelor's degree in a relevant scientific field.
- Some laboratory or quality experience.
- Experience working in a regulated laboratory environment.
- Knowledge of GLP, GCP, 21 CFR Part 11, 21 CFR Part 58, and ICH guidelines.
- Strong attention to detail, organizational skills, critical thinking, and problem-solving abilities.
- Strong written and verbal communication skills.
- Strong computer skills, particularly Microsoft Word and Excel, including intermediate to advanced knowledge of Excel formulas and functions.
- Ability to work independently while collaborating effectively with scientists, analysts, and cross-functional teams.
Nice To Haves
- Experience working in a Quality Control or Quality Assurance capacity within a bioanalytical laboratory preferred.
- Experience with LIMS, laboratory/instrument software, and quality management systems preferred.
- Experience with TrackWise or similar quality systems preferred.
- Experience with project management tools such as Smartsheet preferred.
Responsibilities
- Perform comprehensive quality review of bioanalytical assay data for accuracy, completeness, data integrity, and compliance with GLP/GCP requirements, study protocols, SOPs, and client expectations.
- Review datasets generated from method development, method validation, and sample analysis studies.
- Review study reports, protocols, protocol amendments, and supporting documentation for accuracy and compliance.
- Review sample management documentation and verify samples are appropriately documented and stored in LIMS.
- Review laboratory equipment calibration records, logbooks, and other quality documentation.
- Ensure laboratory records and documentation accurately reflect actual laboratory activities and events.
- Work closely with analysts and scientific staff to investigate and resolve data discrepancies, sample management questions, and documentation issues.
- Maintain accurate QC review records in accordance with SOPs and quality best practices.
- Initiate and coordinate quality events in TrackWise with Lead Scientists.
- Communicate with management and internal departments regarding data review findings and study status.
- Support the development and revision of SOPs, work instructions, methods, study plans, and training materials.
- Assist with training and mentoring team members as appropriate to experience level and qualification.
- Track QC metrics, identify recurring errors or trends, and contribute to continuous improvement initiatives that enhance quality and efficiency.
- Support internal and external audits and maintain awareness of applicable regulatory requirements and industry best practices.
- Complete required training within established timelines and maintain compliance with laboratory safety policies.
Benefits
- Comprehensive Medical, Dental & Vision Insurance with significant employer contributions
- 401(k) Retirement Plan with generous employer matching
- Generous Paid Time Off (PTO), Paid Sick Leave & Company Holidays to support work-life balance
- Employer-funded Health Savings Account (HSA) contributions (for eligible plans), plus Healthcare & Dependent Care Flexible Spending Accounts
- 100% Employer-paid Employee Life Insurance, AD&D, Short- and Long-Term Disability Insurance
- Employee Assistance Program (EAP), mental health resources, and wellness programs
- Family-friendly benefits, including fertility support and maternity resources
- Professional development and career growth opportunities within a leading global CRO/CDMO
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
