Abzena, who provides the most complete set of solutions in integrated early discovery to mid-phase bio-therapeutic and ADC drug development services in the pharmaceutical industry is currently hiring for Quality Control Associate, Stability Coordinator. This role will give you the opportunity to work on a wide range of molecules from companies and academic groups all over the world, including most of the top 20 biopharmaceutical companies.

Summary: The Quality Control Associate will be responsible for performing multiple tasks within the Quality Control (QC) group in support of GMP large-molecule manufacturing activities. This position is expected to oversee and execute stability programs including coordination of internal and external testing for Abzena San Diego projects. Independently defines and executes stability protocol requirements for Abzena San Diego stability testing services. Independently collects, analyzes for trends and generates reports of stability data for Abzena San Diego clients. This position exhibits project coordination skills, the ability to organize and schedule workload to satisfy regulatory and project deadlines as it relates to stability testing, and the ability to effectively convey project status communications to appropriate internal and external customers. The position requires experience within a QC setting and knowledge of GMP/GDP.   

Duties and Responsibilities:

• Ensure that the activities of the stability program are in compliance with effective Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMPs), and International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines.
• Work closely with Program Managers, Clients, and QC analysts to ensure the timely execution of stability protocols, staging, time point pulls, in-house or external testing, and summary reports.
• Write, revise, and review SOPs and GMP documentation as needed, such as stability study protocols, amendments, and summary reports.
• Ensure that stability samples for all projects are properly placed on stability on time at the correct storage conditions and accurate logs are filled out for traceability.
• Follow the requirements of each stability protocol to maintain all required timelines, including ensuring that stability samples are pulled accurately at each time point, tested, and reported to Clients within the designated time frames.
• Coordinate and oversee stability testing, both internal and external.
• Coordinate laboratory testing activities by maintaining stability lab schedule.
• Maintain inventory of stability samples and retains.
• Review testing results and COAs for technical accuracy and compliance.
• Ensure stability chambers are maintained in a calibrated / qualified state and meet ICH guidelines.
• Attend planned meetings as needed to prioritize the stability program.
• Utilize regulatory body accepted statistical software to trend stability data, generating control charts, graphs and tabulations. Recognize potential trends and alert appropriate supervisor(s)about potential issues.
• Participate in discussions regarding the setting of stability specifications and generate recommendations based on statistical trends.
• Interface with auditors during internal, customer and regulatory inspections/audits.
• Report excursions/out of specifications results and conduct investigations as needed.
• Assure the implementation of appropriate and timely corrective actions.
• Initiate change controls and deviations as needed.
• Review equipment qualification reports.
• Performs other related duties as assigned.