Quality Control Stability Coordinator - Abzena

Quality Control Stability Coordinator

Location: San Diego, CA
Area: Quality

Overall Responsibility

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.

 

Typical Duties Include

  • 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 Harmonisation 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.
  • 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.
  • Recognize potential trends and alert the QC Director about potential issues.
  • 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.

 

General Responsibilities:

  • Operates to the highest ethical and moral standards.
  • Complies with Abzena’s policies and procedures.
  • Adheres to quality standards set by regulations and Abzena policies, procedures and mission.
  • Communicates effectively with supervisors, colleagues and subordinates.
  • Ability to participate effectively as a team player in all aspects of Abzena’s business.
  • Travels as needed to attend professional conferences, and train on new technologies.

 

Qualifications/Skills Required:

  • BS degree in a relevant discipline (e.g., chemistry, biological sciences, bioengineering, etc.).
  • Minimum five (5) years experience working in a GMP laboratory/manufacturing environment.
  • Working knowledge of analytical instrumentation and methodologies such as HPLC, wet chemistry, and molecular biology techniques (PCR, immunoassays, SDS-PAGE, ELISA and functional assays) is a plus.
  • Comprehensive and extensive knowledge in the full range of quality control testing and assessment in the pharmaceutical industry.
  • Skill 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 little supervision.
  • Excellent written and oral communication skills.
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