Quality Control Data Reviewer I

Position: Quality Control Data Reviewer I

Salary Range: $68000- 75000

Location: Germantown MD

About Pharmaron

Pharmaron is a global contract research and manufacturing organization (CRO/CDMO) helping pharma and biotech companies bring new therapies to life. With over 25000 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.

Were proud of the impact we make and just last year we supported 887 discovery projects 1100 CMC programs and 1397 clinical trials across all phases. Our teams are involved in everything from small molecules ADCs biologics and gene therapies and we work with more than 3300 global customers. To learn more visit .

What Youll 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 Were Looking For

• Bachelors 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 25000 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

How to Apply:

Ready to seize this incredible opportunity Join us at Pharmaron and be part of a dynamic team driving innovation and excellence in biopharmaceutical research and development. Apply online today!

As an Equal Employment Opportunity and Affirmative Action employer Pharmaron values diversity and inclusion in the workplace fostering an environment where all individuals are empowered to succeed. Join us in our mission to make a difference in the world of life sciences.

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