Quality Assurance Specialist (GCP/GLP)

ADP, Inc.; Germantown (MD); On-site; USD 85,000 - 110,000; Full time

Job summary

Pharmaron is seeking a Quality Assurance Specialist to join our Germantown, MD team. You will support GCP/GLP QA activities, lead audits, and advise on quality issues across regulated studies.

Ideal candidates have a related bachelor’s degree, knowledge of GLP/GCP, experience with eQMS, and strong oral and written communication. This on-site, full-time role offers growth within a premier CRO.

Qualifications

• Bachelor’s degree in a related field is required.
• Knowledge of GLP/GCP bioanalytical regulatory requirements.
• Experience with electronic quality management systems (eQMS) preferred.
• Strong oral and written communication skills.

Responsibilities

• Audit regulated bioanalytical activities and ensure compliance.
• Report non-conformances and track corrective actions.
• Collaborate with science and operations teams on quality issues.
• Support Regulatory and client inspections.
• Prepare standard operating procedures as needed.

Skills

Quality Assurance

Auditing

Communication

Education

Bachelor’s degree in related field

Tools

eQMS

Job description

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Quality Assurance Specialist (GCP/GLP)

FT-Permanent Germantown, MD USA, Germantown, MD, US

30+ days ago Requisition ID: 1055

We are seeking aQuality Assurance Specialist to join our Germantown, MD Quality team!

As aQuality Assurance Specialist,you will be responsible for supporting all aspects of Quality Assurance activities for Good Clinical Practice (GCP) and Good Laboratory Practice (GLP). This role leads the team in supporting business objectives through the effective implementation, management and auditing of the Company’s quality systems.

• Audits the Company’s regulated bioanalytical activities as assigned
• Reports any observed non-compliance with the Company SOPs, protocols, policies, or relevant regulations
• Works with scientific and operational teams to advise on quality-related issues
• Schedules and executes audits of plans, data, and reports for accuracy and compliance for regulated studies
• Audits laboratory activities performed by operations for compliance
• Provides, tracks, and closes written audit reports for all auditing activities
• Contributes to the Quality Assurance Metrics Report to Management
• Provides support for Regulatory and client inspections
• Prepares standard operating procedures for use by the Company, as required
• Bachelor’s degree in related field
• Knowledge of GLP/GCP bioanalytical regulatory requirements
• Experience using electronic quality management systems (eQMS) is preferred
• Strong communication skills: oral and written

Why Should You Apply?

• This is an opportunity for you as a successful Quality Assurance leader to make a real impact in a highly scientific and regulated environment, demonstrate leadership, ambition, and the desire to grow with the department. You will be a highly valued member of our team and have a real impact in a fast-growing and highly respected CRO striving to become the world leader in contract research services.
• Build and shape your career in an environment that sets and commits to the highest standards of scientific research.
• To be part of an expanding team who support each other, embrace and solve technical challenges and put excellence at the heart of all that we do.

About Pharmaron:

Pharmaron is a premier R&D service company supporting the life sciences industry. Founded in 2003, Pharmaron has invested in its people and facilities having established diverse drug R&D service capabilities, ranging from synthetic, medicinal, and analytical chemistry, biology, DMPK, pharmacology, drug safety assessment, radiochemistry and isotopically labelled metabolism, chemical & pharmaceutical development to clinical development. With operations in China, US and UK staffed by over 13,000 employees, Pharmaron has an excellent track record in the delivery of R&D solutions to its partners in North America, Europe, Japan and China. Pharmaron continues to expand its services in the US and globally.