Category: Scientific & Clinical
Title: Quality Assurance Associate - I
Location: San Diego, CA
Start date: ASAP
- Provide exceptional customer service to internal and external customers in all assigned tasks.
- Maintain programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMP)
- Provide floor support for GMP activities
- Monitor for GMP compliance of all in-process activities during GMP processing.
- Perform AQL particle inspection of in-process product vials prior to packaging.
- Gown qualified for entry into controlled manufacturing areas to perform quality functions as assigned.
- Perform real time review of executed Batch Documentation and prepare for eventual disposition by QA management.
- Organize documentation for Batch History Files and scan files.
- Ability to search, document and generate quality event reports for Batch Release.
- Assist with regulatory inspections and partner audits with management oversight.
- Maintain databases as required
- BS/BA degree in scientific discipline from an accredited college or university or equivalent preferred or equivalent work experience.
- Minimum 1 year of relevant Pharmaceutical Industry Quality Assurance experience preferred.
- Strong knowledge of GMP’s and their application
- Prior experience with Batch Documentation review
- Ability to work proactively and cooperatively with managers and operational staff to solve quality problems
- Ability to manage multiple responsibilities with a high degree of self motivation
- Good written, oral and interpersonal English communication skills
- Ability to use Microsoft Word and Excel applications
Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.