Associate, Quality Assurance (GMP) - QA14
Menlo Park, California, United States
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
- 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.
- Bachelor’s degree in life sciences