Quality Assurance Associate I, GMP Systems Compliance and Data Integrity

Quality Assurance Associate I, GMP Systems Compliance and Data Integrity

Position Summary:

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.

Catalent Pharma Solutions in San Diego is a premier pharmaceutical chemistry development and manufacturing organization supporting the pharmaceutical and biotechnology industries. We focus on bringing client drug compounds from discovery to the clinic with services that include analytical development, pre-formulation testing, formulation development, GMP (Good Manufacturing Practices) manufacturing and stability storage and testing as well as Clinical Supply Services.  At Catalent San Diego, we recruit and develop exceptional individuals with a passion for science and determination to excel. We offer a technically challenging and stimulating environment and the opportunity to learn from the best.

Catalent Pharma in San Diego, CA is hiring a Quality Assurance Associate I, GMP Systems Compliance and Data Integrity. An individual in this role is responsible for a wide variety of activities related to supporting, maintaining, and ensuring data integrity and compliance for GMP systems. They should develop an understanding of the site Quality systems and will begin to expand their knowledge of applicable GMP regulations and equipment CSV (Computer System Validation) and DI (Data Integrity) requirements. This individual must demonstrate excellent communication, critical thinking, and organizational skills.  This position gives opportunities to develop expertise and expand knowledge of overall site-wide operations in a fast-paced, early Phase-focused, dynamic setting.

This is a full-time hourly position: Monday – Friday, 8am-5pm on-site (flexibility in schedule outside of core business hours).

Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee. 

The Role:

• Review and approval of equipment related documentation: Equipment onboarding, Calibration certificates/reports, Validation/qualification reports, System access reviews
• Performing manufacturing support activities: Production Audits, Label Documentation Review, Shipment Documentation/Verification
• Review and approval of site procedures, such as Standard Operating Procedures (SOPs), FORMs, and validation protocols
• Assisting with review and approval of change controls related to site GMP systems and assisting with GMP system periodic reviews
• Assisting with DI compliance assessments of new GMP systems.  Enforcing CSV guidelines, policies and procedures for production and analytical equipment, and IT applications
• Assisting with plans, procedures, and requirements to address data integrity gaps for GMP systems
• Assisting with identification of data integrity risks and proposing improvement plans. This includes identifying data and systems issues, defining requirements, and recommending enhancements for system features and related processes
• Other duties as assigned

The Candidate:

• Candidate must have a Bachelor’s (BS/BA) degree in science, business or engineering
• No experience is required with a Bachelor’s degree, but candidates with over 1 year of GMP manufacturing experience are highly preferred
• Candidate must also be highly detail-oriented and organized, able to work both independently and as a team player with a positive attitude
• Must have familiarity with following ISO/GMP procedures in a regulated environment
• Experience with equipment verification/calibration and supporting documentation highly desired
• Experience with Blue Mountain, TrackWise, and Microsoft Office preferred
• Physical requirements: Individual may be required to sit, stand, walk regularly and occasionally lift up to 20 pounds; ability to communicate orally with customers, vendors, and co-workers. Regular use of telephone and email. Hearing, vision, and s