Contract QA Specialist

Pharmaron • San Diego, CA

19h • Onsite

About The Position

The Contract QA Specialist is responsible for supporting quality assurance operations, including processing change orders and deviations, managing archival materials, and ensuring compliance with Standard Operating Procedures (SOPs) and Good Laboratory Practice (GLP) principles. This role also contributes to the review of study data to ensure accuracy, consistency, and completeness.

Requirements

• Minimum 1 year of QA or document control experience in a regulated pharmaceutical or biotechnology environment
• Strong attention to detail and analytical thinking skills
• Excellent written, verbal, and organizational communication skills
• Ability to review and interpret technical documentation with accuracy
• Familiarity with GLP standards and regulated environments
• Ability to communicate effectively with multidisciplinary teams and external partners

Nice To Haves

• Experience with eQCM or similar electronic quality/document management systems
• Experience with archiving or records management
• Experience with ISO 9001:2015 Quality Systems

Responsibilities

• Process change orders and updates through the eQCM system in alignment with management direction
• Maintain inventory of samples, specimens, blocks, and slides
• Assist with packaging, labeling, shipment, relocation, or disposal of samples and materials
• Organize, label, and archive paper-based study data for on-site storage
• Upload tracking sheets and documentation into the electronic document management system (eQCM)
• Review forms, reports, and study data for completeness, accuracy, consistency, and adherence to protocols, SOPs, and regulatory requirements
• Scan and organize correspondence, raw data, and controlled documents into eQCM
• Collaborate with cross-functional teams to support QA processes and ensure compliance
• Communicate effectively with team members, management, and clients

What This Job Offers

• Career Level: Entry Level
• Education Level: No Education Listed
• Number of Employees: 5,001-10,000 employees