Manager Quality Control

1 month ago

Salt Lake City, United States Teva Full time

Any equivalent combination of education, training and/or experience that fulfills the requirements of the position will be considered. 

  • Education/Certification/Experience:
  • Bachelor of Science degree in Biology, Microbiology, Chemistry or related field from an accredited college or university required.
  • 5+ years of professional experience in a pharmaceutical microbiology laboratory or an equivalent combination of training and experience. 
  • Previous experience managing junior microbiologists in a micro lab setting required.
  • Requires experience with an in-depth knowledge of cGMP and other applicable industry regulatory requirements as they relate to the production of pharmaceutical products and associated quality systems.
  • Requires advanced understanding of the principles of analytical chemistry and microbiology as it applies to the responsible area.
  • Advanced abilities related to technical writing and documentation activities.  Able to design and document a process with little to no oversight.
  • Advanced understanding of the fundamental principles and theory behind a variety of analytical techniques, including, but not limited to, HPLC, GC, IR, UV Spectroscopy and GCMS.
     

​​​​​​​Skills/Knowledge/Abilities:

  • Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and other regulatory requirements.
  • Microbiology and microbiological test method development and validation.
  • Sampling methods, automated identification and quality control systems.
  • Classical microbiology techniques (i.e. gram staining, pour and streak plating, culture maintenance, aseptic techniques).
  • Microscope, autoclave, and laminar flow hood usage.
  • Mathematics and statistics.
  • Prefer management experience in a clean-room microbiology environment.
  • Sample preparation techniques.
  • Computer proficiency with comprehensive working knowledge of MS Office products, Learning Management Systems (LMS), ERP systems such as SAP or Oracle and manufacturing/quality systems such as Trackwise and Qdocs.
  • Communicate effectively with excellent written and oral communication skills.
  • Self-directed with ability to organize and prioritize work.
  • Ability to identify the developmental needs of others and provide coaching, mentoring or encouragement to help others improve their knowledge or skills.
  • Ability to motivate, influence and lead others with and/or without direct supervisory authority.
  • Ability to positively manage conflict, provide difficult feedback and negotiate resolution.
  • Ability to build and maintain collaborative relationships between teams, departments and business units.
  • Ability to demonstrate sound judgment and decision making.
  • Ability to analyze information and create metrics relevant to the business objectives.

Problem Solving:.

  • Proactively works on problems of a moderate to complex scope where evaluation of contributing factors requires the analysis of situations or data and an in-depth knowledge and evaluation of various known and unknown factors.
  • Seeks out all resources when selecting methods and techniques for obtaining results.
  • Acts independently and proactively to recommend and administer methods and procedures for problem resolution.
     

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