QA Associate, Clinical Supplies

Quality Assurance Associate, Clinical Supplies

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 Solutions in San Diego, CA is hiring a Quality Assurance (QA) Associate for our Clinical Supplies team. Under general supervision, the QA Associate performs work that is varied and that may be somewhat difficult in character, but usually involves limited responsibility. This individual follows established protocols and work plans, and may be assisted by QA Specialists and Sr. Specialists. This role is essential to comply with divisional and site Environmental Health and Safety (EHS) requirements.

This is a full-time hourly position on-site: Monday-Friday on 1st shift (day shift).

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:

• Responsible for inspection of incoming materials for GMP production. Assist with packaging floor activities for primary and secondary (equipment/room approval, facility compliance, auditing, label inspection, line clearance, etc.)
• Reviews production batch records, logbooks and other associated documents. Performs Quality verification of just-in-time labeling activities
• Performs document issuance, scanning, filing and archival activities. Revises SOPs, Work Instructions and Forms pertaining to their area of focus, as needed. Assists in the execution of efficiency improvement projects with guidance
• Ensures that products are manufactured, packaged, and tested according to applicable FDA guidelines, GXPs regulations and internal SOPs
• Participates in Quality programs, procedures and controls to ensure that products conform to established standards and agency guidelines. Ensures gathering of data, investigations and deviations are timely and compliant
• Follows all Good Documentation Practices and cGMPs to ensure compliance to applicable FDA guidelines and MHRA guidelines
• Respond and interact with internal and external clients in a professional and timely manner
• Other duties as assigned.

The Candidate:

• Associate’s Degree or equivalent knowledge and experience is required. Lean Six Sigma or ASQ Certification is preferred
• Ability to follow and provide a variety of instructions furnished in written, oral, diagram, or schedule form. Must be able to use existing procedures to solve routine and non-routine problems
• Must be able to utilize all elements of the quality system to identify, classify and control the status of incoming materials
• Recognizes unmet needs within department and business
• Mathematical and scientific reasoning ability. Ability to identify aberrant data and potential quality/compliance concerns escalating to management
• Physical Requirements: On an average 8-hour day this position requires the ability to walk, sit and stand, use hands to handle or feel, reach with hands and arms at or above shoulder height and below waist height, climb or balance, stoop, kneel, crouch, or crawl; talk and hear, smell and lift up to 40 pounds. Specific vision requirements including reading of written documents, visual inspection of materials and use of computer monitor screen frequently