Quality Assurance Specialist

Position : Bioanalytical Quality Assurance Specialist

Salary : $70,000 to $80,000 per year

Location : Germantown, MD (ON-SITE)

About Pharmaron :

Pharmaron is a global CRO (Contract Research Organization) helping pharma and biotech companies bring new therapies to life. With over 21,000 employees worldwide across 23 locations in the US, UK and China, 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 over 780 discovery projects , 1,000+ CMC programmes , and 1,000+ 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 3,000 global customers . To learn more, visit .

Responsibilities :

• Comply with the Company's Health and Safety, and Radiation Safety Program.
• Quality systems - to audit assigned aspects of the Company's regulated activities, with the exception of the Finance Department, and report to Test Site Management any non-compliance to the Company SOPs, protocols, policies, or relevant regulations.
• Identify critical non-compliances and report them immediately to the Study Lead, Director of Quality Assurance, and Test Site Management.
• Provide advice and support to assigned functions with regards to quality issues.
• Schedule and execute audits of plans, data, and reports for accuracy and compliance for regulated studies.
• Audit laboratory activities performed by operations for compliance.
• Schedule and execute facility audits of equipment, systems, and processes in compliance with QAU SOPs.
• Provide, track, and close written audit reports for all auditing activities.
• Contribute to the Quality Assurance Metrics Report to Management.
• Provide support for Regulatory and client inspections.
• Quality Assurance Unit - to adhere to the operations of the QAU and to make recommendations for further implementation or improvement of any of its systems.
• To prepare standard operating procedures for use by the Company as required.
• To assist the Company, meet its business objectives by demonstrating to Sponsors the quality processes and continuous improvement activities within the Company.

What We're Looking For :

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 21,000 employees and operations in the U.S., the U.K. and China. 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 Centred" 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 :

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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