Senior Quality Associate

• Support implementation, maintenance, and improvement of the Quality Management System
• Support Contract Development and Manufacturing Organization (CDMO) and Contract Testing Lab (CTL) management
• Author and review Standard Operating Procedures (SOPs)
• Provide Quality Onboarding training
• Support vendor management activities
• Review and approve vendor documentation
• Review executed manufacturing records in support of product disposition
• Support computer system validation activities
• Support quality performance and continuous improvement activities
• Assist in compiling metrics for Quality Management Review
• Perform other duties as assigned

Requirements

• Bachelor's degree in Biology, Chemistry or other relevant scientific discipline preferred
• 4+ years of full-time cGMP Quality Assurance experience
• Travel required up to 35%
• Experience with eQMS (e.g., ACE, TrackWise)
• Working knowledge of current industry practices and standards in an FDA-regulated biotechnology company
• Excellent record keeping and documentation skills
• Strong communication skills, both verbal and written, with the ability to concisely present information in cross-functional settings
• Experience working with CDMOs preferred
• Proficient use of MS Office products
• Ability to rapidly adapt to changing environment and circumstances requiring flexibility, tolerance, and a great sense of urgency while ensuring that all cGMP and regulatory requirements are met
• Ability to work effectively both independently and with other team members

Core Competencies

Demonstrates expertise in Quality Management Systems, cGMP Quality Assurance, and vendor management within FDA-regulated environments. Proficient in authoring SOPs, conducting quality training, and supporting continuous improvement initiatives.

Highest-signal resume keywords

• CGMP Quality Assurance Experience
• EQMS Experience
• Standard Operating Procedures (SOPs) Authoring
• Vendor Management
• Quality Management System Support

Hard Skills

• Quality Management System
• CGMP
• Standard Operating Procedures (SOPs)
• Quality Metrics Compilation
• Computer System Validation
• Documentation Skills
• Quality Onboarding Training
• Manufacturing Record Review
• Regulatory Compliance
• Biology or Chemistry Degree

Soft Skills

• Strong Communication Skills
• Adaptability
• Team Collaboration
• Flexibility
• Sense of Urgency

Industry Keywords

• FDA-Regulated
• Biotechnology
• Contract Development and Manufacturing Organization (CDMO)
• Contract Testing Lab (CTL)
• Quality Performance Improvement

Tools & Technologies

• EQMS (ACE, TrackWise)
• MS Office