Quality Control Data Reviewer I

Pharmaron; Germantown (MD); On-site; USD 68,000 - 75,000; Full time

Benefits offered by this job

Medical, Dental & Vision Insurance

401(k) Retirement Plan

Paid Time Off & Holidays

HSA contributions

Job summary

Pharmaron in Germantown, MD is seeking a Quality Control Data Reviewer I to perform comprehensive QC data reviews and ensure GLP/GCP compliance. The role involves evaluating bioanalytical assay data, review of method development, validation, and sample analysis documentation.

You will coordinate QC events in TrackWise, maintain records, and collaborate with analysts and cross-functional teams. A bachelor’s degree in a relevant scientific field and strong Excel/LIMS skills are required, with

Qualifications

• Bachelor's degree in a relevant scientific field.
• QC Data Reviewer I: Some laboratory or quality experience.
• QC Data Reviewer II: 2+ years of relevant quality experience.
• QC Data Reviewer III: 5+ years of relevant quality experience.
• Experience with GLP, GCP, 21 CFR Part 11, 21 CFR Part 58, and ICH guidelines.
• Experience with LIMS, quality management systems, and TrackWise preferred.
• Strong attention to detail, organizational skills, critical thinking, and problem-solving abilities.

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.
• Maintain accurate QC review records in accordance with SOPs and quality best practices.
• 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.

Skills

Quality control

Data review

Attention to detail

Communication

Excel

LIMS

TrackWise

Education

Bachelor's degree in a relevant scientific field

Tools

LIMS

TrackWise

Smartsheet

Microsoft Excel

Job description

Position: Quality Control Data Reviewer I
Salary Range: $68,000- 75,000
Location: Germantown, MD
About PharmaronPharmaron is a global contract research and manufacturing organization (CRO/CDMO) helping pharma and biotech companies bring new therapies to life. With over 25,000 employees worldwide across 28 locations in the US, UK, China, and Singapore, we support drug discovery through to manufacturing with fully integrated high-quality services. We're proud of the impact we make and just last year, we supported 887 discovery projects, 1,100+ CMC programs, and 1,397 clinical trials across all phases. Our teams are involved in everything from small molecules, ADC's, biologics, and gene therapies and we work with more than 3,300 global customers. To learn more, visit www.pharmaron.com.

What You\'ll Do

• 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.

What We\'re Looking For

• Bachelor\'s degree in a relevant scientific field.
• QC Data Reviewer I: Some laboratory or quality experience.
• QC Data Reviewer II: 2+ years of relevant quality experience.
• QC Data Reviewer III: 5+ years of relevant quality experience.
• Experience working in a Quality Control or Quality Assurance capacity within a bioanalytical laboratory preferred.
• 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.
• 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.
• Ability to work independently while collaborating effectively with scientists, analysts, and cross-functional teams.
• For senior-level roles, demonstrated ability to handle complex data-review issues, mentor team members, support process improvements, and represent the QC function during audits.

Why Pharmaron?Pharmaron is a premier service provider for the life sciences industry. Founded in 2004, Pharmaron has invested in its people and facilities and established a broad spectrum of research, development, and manufacturing service capabilities throughout the entire drug discovery, preclinical, and clinical development process across multiple therapeutic modalities, including small molecules, biologics, and CGT products. With over 25,000 employees and operations in the US, UK, China, and Singapore. Pharmaron has an excellent track record in delivering R&D solutions to its partners in North America, Europe, Japan, and China.

Collaborative Culture: You will thrive in our inclusive and collaborative environment, where teamwork and innovation go hand in hand. Here, your voice matters, and your contributions make a real impact. "Employees Number One" and "Clients Centered" are the core cultural values at Pharmaron. Our culture, which sets Pharmaron apart from other organizations, has evolved from our deep commitment to our employees, partners, and collaborators.

• Benefits: As part of our commitment to your well-being, we offer a comprehensive benefits package:
• 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