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Quality Control Microbiology Supervisor - College

Company: Kelly Services
Location: College Station
Posted on: September 24, 2022

Job Description:

Kelly Science and Clinical is currently seeking candidates for a Quality Control Supervisor of Microbiology for a Biopharma company in College Station, TX. The overall responsibility of this role is the day to day management of the QC Microbiology team including hiring, performance management, and development of staff. The Supervisor serves as the subject matter expert of QC Microbiology practices and procedures and serves as the main point-of-contact for all activities related to meeting the compliance, supply, and objectives of the company and the department.Responsibilities:

  • Responsible for planning, scheduling, and organizing all activities related to the Quality Control Microbiology department.
  • Responsible for creation of all QC Microbiology quality systems and implementation of those systems.
  • Management of all Microbiology internal and off site testing.
  • Collaborate with cross-functional teams to resolve problems and challenges.
  • Responsible for participation in internal audits, client audits and agency inspections of the site.
  • Responsible for development and coordination of QC Microbiology capabilities, procedures, business processes, and budget.
  • Support cGMP manufacture and supply of high-quality cell and gene therapy products including oversight of cGMP sample handling, testing, and QC release.
  • Develop, implement, and monitor QC Microbiology programs and procedures to ensure compliance with GMP standards, FDA, EMA and other regulatory body regulations.
  • Maintain current knowledge base of regulations, corporate policies, and industry best practices to ensure the QC function remains in compliance with company requirements and global regulations. Qualifications:
    • BS/BA in the sciences, preferably in Microbiology, Biochemistry, Biotechnology, or related.
    • 8+ years GMP experience in microbiology, pharmaceutical, manufacturing, or laboratory environment.
    • Expert knowledge of GMP, FDA and EMA regulatory requirements applicable to Biologics.
    • Knowledge of Quality Control Microbiology system development including creation of SOPs, Work Instructions, etc.
    • Strong knowledge of current industry trends and has the ability to use the latest technologies.
    • Ability to build strong teams, including coaching/developing, training, motivating/empowering, and resolving conflicts. Job Details
      • Job Type: Direct Hire
      • Work Schedule: Monday-Friday, 8:00am-5:00pm
      • Salary Range: $95K-$110K + annual bonus If you meet the above qualifications, please submit your resume for immediate consideration for this high priority role!

Keywords: Kelly Services, College Station , Quality Control Microbiology Supervisor - College, Other , College Station, Texas

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