Associate, Quality Assurance (GMP)

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