Quality Assurance Associate

Quality Assurance / Quality Control Associate

Client is seeking an entry-level Quality Assurance / Quality Control Associate to support clinical manufacturing and drug development activities in a GMP-regulated environment. This is a great opportunity for individuals looking to begin their careers in biotech, particularly in quality and regulatory compliance.

Key Responsibilities:

• Receive and qualify incoming materials and reagents according to GMP requirements
• Review batch records, laboratory notebooks, and QC testing results for completeness and compliance
• Assist in deviation investigations and document change control processes
• Support the organization and maintenance of the electronic document control system
• Ensure compliance with internal SOPs and applicable cGMP regulations
• Participate in internal audits and prepare documentation for regulatory inspections
• Assist with data verification and archiving of quality-related records
• Contribute to creation and revisions of SOPs, forms, and controlled documents

Qualifications:

• Associate's or Bachelor's degree in Biomedical Sciences, Life Sciences, or a related field
• Candidates with degrees in Data Management, Health Information Technology, Technical Writing, Supply Chain Management, or Communications who are looking to enter the biotech industry are also encouraged to apply
• Strong attention to detail and organizational skills
• Effective written and verbal communication skills
• Ability to review and interpret technical documents and records
• Self-motivated with the ability to work independently and as part of a team
• Comfortable using digital tools and electronic documentation systems
• Willingness to work in a GMP-regulated laboratory environment