Associate, Quality Assurance (GMP) - QA14


Full-time

Menlo Park, California, United States

Quality Assurance

Location: Menlo Park, CA

Reporting to: Senior Quality Assurance Manager

Orchard Therapeutics is an international biotechnology company dedicated to bringing transformative gene therapies to patients with serious and life-threatening orphan diseases. Created two years ago, it is in an exciting start-up phase where a Quality Assurance professional can have a real impact on the work and foundations that are being created.

KEY ELEMENTS AND RESPONSIBILITIES

  • Review and approve Process and Analytical Development study protocols and reports
  • Perform data integrity verification for internal activities
  • Ensure compliance with the Equipment Qualification Program
  • Review equipment enrollment and equipment qualification protocols and reports
  • Support establishment of Quality Control methods and procedures
  • Review Batch records as needed
  • Write, revise and periodically review SOPs to support continuous improvement of the Quality System
  • Communicate issues to Orchard Therapeutics management in a timely manner.
  • Supports the preparation of regulatory submission as needed
  • Track and trend data and provide reports to management, as required
  • Support internal and external audit as needed

Requirements

  • Experience with document review and Good documentation Practices
  • Knowledge of US GMP, EU experience is a plus
  • 2-4 years of experience in the pharmaceutical/bio-pharm manufacturing industry
  • Knowledge of manufacturing and testing practices in regulated environment

SKILLS & ABILITIES

  • Proven ability to work with a high level of integrity, accuracy, and attention to detail.
  • Self-motivated, assertive, and self-confident with the ability to act with urgency and passion
  • Strong organizational skills in order to maintain a high level of productivity, and priority-setting in order to complete assignments on-time and on-budget
  • Excellent oral and written communication skills for effectively interfacing with all levels of management and departments within the company
  • Willingness to work collaboratively by incorporating diverse perspectives
  • Proactively seeks out and recommends process improvements.
  • Resourceful, creative, enthusiastic, and results-oriented.
  • Entrepreneurial, enjoys working in a fast-paced, small-company environment.

EDUCATION

  • Bachelor’s degree in life sciences