Purpose & Scope:

The primary purpose of the Quality Systems Associate I is to support the Quality Assurance team in maintaining Standard Operating Procedures, Batch Records, Forms, Templates, Process Support Documentation & Training Materials. This position will have opportunities to train team members and integrate compliance initiatives cross-functionally and identify areas for quality improvements.

Essential Job Responsibilities: 

• Maintains and optimizes Quality Assurance programs including (but not limited to) document control, lot disposition, incident management and material management.
• Maintains Standard Operating Procedures, Batch Records, Forms/Templates, Process Support Documentation & Training Materials
• Edits documentation for clarity, consistency, organization, and effectiveness
• Performs Executed Logbook and Executed Batch Record reviews
• Works directly with Subject Matter Experts to develop content or provide meaningful feedback to improve structure and flow of documentation
• Participates in customer meetings and identifies required potential changes to documentation, takes meeting minutes and communicates status to cross-functional audiences
• Develops training materials, generates document solutions for optimization and risk mitigation, creates improved communication mechanisms
• Performs other duties as assigned or special projects as needed

Quantitative Dimensions:

• Direct impact on the company’s Quality Systems

Organizational Context:

• Reports to Quality Assurance Management
• Collaborates regularly with Production and R&D teams

Basic Qualifications:

• BA/BS degree or equivalent work experience in Quality Assurance.
• Strong attention to detail and accuracy of work.
• Ability to explain and interpret information from internal and external sources
• Ability to think quickly and perform complex tasks
• Comfort executing routine tasks and generating work instructions to train peers
• Cross-functional communication skills and positive attitude with customer service focus
• Strong organizational, time management, and problem solving skills
• Ability to work independently with supervision and ability to effectively collaborate with other teams
• Strong work ethic with a passion for working in a fast-paced, dynamic and diverse work environment

Preferred Qualifications:

• Preferably 1-2 years of related Quality Assurance experience working in a lab environment
• GMP/GLP experience preferred
• Familiarity with electronic databases (for example: EDMS, SharePoint, Trackwise)
• Experience writing Standard Operating Procedures (SOPs) and Production Batch Records
• Biology or Bio-engineering background related to stem cell culturing, plasmid and rAAV production and product development is preferable