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QC Investigations Specialist

Novato, CA 94949

Posted: 09/21/2023 Employment Type: Contract Job Category: Quality and Compliance Job Number: 585627 Is job remote?: No Country: United States

Job Description

Role Summary

The QC Investigations Specialist is responsible for the execution and management of laboratory investigations in the quality management system. The primary area of responsibility for this position is to work cross-collaboratively with supervisors, leads and QC analysts to conduct investigations and identify root cause(s) for laboratory investigations, deviations & calibration events, environmental monitoring alert, action, adverse trend investigations. 

The QC Investigations Specialist must have a working knowledge of root cause analysis (RCA) methodology and testing methods (e.g Bioburden, Endotoxin, A280, HPLC/UPLC, PCR, ELISA, Bradford, Activity and Bioassays) to support QC investigations involving multiple manufacturing modalities (e.g. Gene Therapy, Biologics, Small Molecules). The scope covers both clinical programs and commercial products.

The candidate should be able to complete work under minimal supervision, in accordance with cGMP guidelines, and have exhibit effective time management and communication skills, and be able to work in a team-oriented culture of open feedback.

The candidate should also be able to anticipate and implement solutions that actively prevent and/or remove obstacles related to ongoing issues and allow for continuous improvement.

Role Responsibilities
  • Lead laboratory investigations (LIRs) for OOS, OOE, OOTs and system suitability failures
  • Lead deviation investigations related to QC laboratory, excursions, and adverse trends.
  • Work with QC team for data gathering, observing processes for investigations, and performance of associate interview.
  • Build cross-functional workgroups and facilitate identification of the true root cause utilizing root cause analysis tools (fishbone, 5 Why’s, etc.).
  • Assign child records to appropriate groups and provide guidance on investigations to operational staff.
  • Aligning internal review team and area subject matter experts on an agreed investigational path forward.
  • Identify proper CAPA after investigation process is complete plus, if applicable, sequential Effectiveness Check strategy, and provide ownership whenever necessary.
  • Identify trends and work with the appropriate teams on resolution.
  • Technical writing of investigations, translating very complex and challenging scientific events into a concise, accurate and cohesive report.
  • Ensure that Quality Control investigations are in a state of compliance with all company standards and current industry and regulatory standards.
  • Work with management and quality assurance in on-time closures of Deviations and LIRs.
  • Help develop and improve policies, procedures, and business practices to maintain and/or enhance compliance status.
  • Other duties as assigned.
B.S. degree, or equivalent, in a biological or biochemical science and at least 4 years of experience in a pharmaceutical laboratory, with at least 2 years as part of a QC organization.
  • Detailed knowledge of quality management systems, current Good Manufacturing Practices, expertise with QC principles and compliance requirements.
  • Demonstrated working knowledge and critical thinking with respect to certified functional activities, with subject matter expertise on several technical modules or quality management systems.
  • Knowledge of various quality tools including fishbone, 5 Why’s etc.
  • Excellent documentation, written and verbal communication skills are essential.
  • Experience leading investigations and writing technical investigation reports is preferred.
  • Expertise with quality management systems and laboratory software functions, such as Veeva, MODA or LIMS, is optimal.
  • Management of multiple projects and timelines concurrently. Ability to adhere to standard timeline and escalate actions appropriately for resolution in a timely manner.
  • Must possess the ability to perform routine and non-routine tasks under minimal supervision.
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