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.
Minimum of B.S. degree in a scientific discipline
Minimum 1-4 years of relevant Quality Control industry experience in a GMP environment.
Knowledge of the theoretical and practical aspects of analytical methods utilized to characterize large molecule therapeutics including: U/HPLC, CE, cIEF, ELISA, SDS PAGE and compendial testing.
Demonstrated experience conducting stability program coordination, including design of protocol studies, technical writing, and trending of data using JMP or equivalent statistical trending program.
Demonstrated understanding of USP, EP and ICH guidelines.
Strong written and oral communication skills, proficient with Microsoft Office software.
Comprehensive and extensive knowledge in the full range of quality control testing and assessment in the pharmaceutical industry.
Ability to accurately and precisely document and record laboratory activities, results, and conclusions.
Excellent attention to detail.
Ability to work well under pressure, multi-task and prioritize work assignments with minimal supervision.
Excellent written and oral communication skills.
Internal Number: 154
Abzena is a life sciences group with its headquarters in the UK and two sites in the US. Abzena provides the most complete set of solutions in integrated early discovery to mid-phase biotherapeutic and ADC drug development services in the pharmaceutical industry.Working with companies and academic groups all over the world, including most of the top 20 biopharmaceutical companies, Abzena supports the development and manufacture of better treatments for patients. Multiple antibodies which have been created using Abzena’s technologies are currently being progressed through clinical development by our licensees.