Quality Assurance Manager

6 days ago

South Plainfield, New Jersey, United States Kashiv BioSciences LLC Full time
Job Title: Quality Assurance Manager

Job Summary:

Kashiv BioSciences LLC is seeking a highly skilled Quality Assurance Manager to oversee and direct the activities of our QA organization. The successful candidate will have a thorough knowledge of laboratory practices, including testing and OOS investigations, and QMS systems such as Deviations, CAPAs, and Change Controls.

Key Responsibilities:
  • Investigation and Resolution: Oversee thorough and compliant investigations, including Deviations and CAPAs, to ensure timely resolution of issues.
  • Process Improvement: Develop, initiate, manage, and implement improvements to quality systems and processes to drive continuous improvement.
  • Regulatory Compliance: Ensure that all operations are compliant with cGMPs regulatory requirements, including review and approval of SOP system documents.
  • Quality Oversight: Oversee review and approval of raw materials and components, manufacturing documents, and quality control documents to ensure cGMP compliance.
  • Team Leadership: Supervise and direct the activities of QA staff, including mentoring and training to ensure effective quality systems.
  • Metrics and Trend Analysis: Monitor effectiveness of Quality Systems, developing event metrics such as number and type of batch record errors, training deviations, etc., and trend analysis for management review.
  • Vendor Qualification: Conduct qualification audits on vendor/supplier.
  • Root Cause Analysis: Participate in deviations and OOS result investigations, ensuring proper root-cause analysis and implementation of corrective and preventive actions.
  • Quality Review Board: Plan and implement Quality Review Board meetings to ensure effective quality systems.
  • Collaboration: Interface with all levels of Kashiv team to resolve issues and drive timely resolution of projects, investigations, and process improvements.
Requirements:
  • Education: Bachelor or Master degree in Life Science or other related discipline.
  • Experience: Minimum of 10 years of relevant experience in pharmaceutical quality assurance/control environment, with minimum of 3 years in a direct supervisory role.
  • Skills: Experience of GMP document review, Quality Management System maintenance, quality auditing, and understanding of requirements and procedures related to document control and quality assurance.

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