Vacancy expired!
Biotech company in Santa Barbara / Goleta seeks an experienced, enthusiastic team member for their growing Quality Assurance Department
Typical responsibilities include
Under the direction of the Department Head assists in the management and improvement of our Quality Management System (QMS) to ensure compliance with regulatory requirements and standards (FDA, ISO, IVDR)
● Performs product releases, reviews and approves device history files and related quality records
● Carries out daily environmental monitoring of laboratory equipment
● Maintains equipment management system: calibration, service, and maintenance schedule
● Coordinates complaint process, supports evaluation and resolution of complaints
● Performs data quality review and trending for compliance
● Assists with nonconformances, preventive/corrective action investigations, and root cause analysis, as assigned to ensure documentation is complete, accurate, and closed in a timely manner
● Identifies compliance weaknesses and suggests implementation of workable solutions
● Assists with training other team members to quality policies, procedures or work instructions
● Assists with document control and change control processes
● Supports product and process risk management activities in compliance with regulatory standards
● Commonly exercises decision-making and discretion in performing job-related tasks
● Regularly interfaces with other departments (laboratory and administrative staff)
● Performs other related duties to support the QMS as assigned
Skills and Experience
● Excellent written, verbal, and interpersonal communication skills
● Excellent problem-solving and critical thinking skills
● Self-motivated with strong time management skills, capable of working with minimal supervision
● Ability to work well in a cross-functional, collaborative team of a small company
● Experience with word processing, spreadsheets, document organization and electronic filing
Education and Training
● Bachelor’s Degree and one year experience with quality systems or equivalent combination of education, training, and experience
● Experience with Quality Systems, ISO 13485 and general knowledge of Good Manufacturing Practices (GMP) preferred. We will provide GMP and ISO 13485 compliance support as necessary
This is a permanent, full-time position with 35 hours per week. Please indicate when you would be available to begin work and salary expectations (salary negotiable). We are an equal opportunity employer.
