Quality Assurance Specialist (GCP/GLP) jobs in United States
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Pharmaron · 4 months ago

Quality Assurance Specialist (GCP/GLP)

Pharmaron is a premier R&D service company supporting the life sciences industry. They are seeking a Quality Assurance Specialist to support all aspects of Quality Assurance activities for Good Clinical Practice (GCP) and Good Laboratory Practice (GLP), leading the team in implementing and managing the company’s quality systems.

BiotechnologyChemicalPharmaceutical

Responsibilities

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

Qualification

GLP/GCP knowledgeEQMS experienceQuality Assurance auditing’s degreeCommunication skills

Required

Bachelor's degree in related field
Knowledge of GLP/GCP bioanalytical regulatory requirements
Strong communication skills: oral and written

Preferred

Experience using electronic quality management systems (eQMS)

Company

Pharmaron

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Pharmaron is a contract research organization that offers research and development services for the life science industries.

Funding

Current Stage
Public Company
Total Funding
$907.82M
Key Investors
GL Capital
2019-11-22Post Ipo Equity· $587.82M
2019-01-28IPO
2015-12-14Series Unknown· $280M

Leadership Team

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Katherine Lee
Chief Business Officer
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Company data provided by crunchbase