Specialist Manufacturing

Thousand Oaks, CA 91320-1799

Posted: 07/09/2020 Employment Type: Contract Industry: Business Professional Job Number: 7929

Job Description


Our client is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.


Duties:
  • Preferably experience in a quality role.
  • Seasoned self-starter, excellent communication and interpersonal skills.
  • This individual will be owning/executing change controls for Supplier changes.
  • This will include coordinating team activities, making sure hitting milestones and on track with project plan.
  • Average person- Bio pharma experience or background sector with solid Project Management and Quality Management skills and experience.
  • The Specialist is expected to own Change Controls.
  • Experience with managing multiple records is important and TrackWise user knowledge is an advantage.
  • May act as the External Supply Lead driving consistency across all Specialists in the space.
  • Will be required to communicate with many functions within the organization, facilitate development of solutions to critical business issues, and effectively define objectives to enable effective metric generation and reporting.
  • May serve as the primary point of contact between Site Plant Quality and the corporate Supplier Quality Management team to ensure the quality of raw materials used at the sites.


Basic Qualifications:
  • Master’ s degree and 4 years of Quality and/or Manufacturing experience
  • OR
  • Bachelor’ s degree and 6 years of Quality and/or Manufacturing experience
  • OR
  • Associate degree and 8 years of Quality and/or Manufacturing experience
  • OR
  • High school diploma / GED and 10 years Quality and/or Manufacturing experience


Preferred Qualifications:
  • 6+ years related work experience (manufacturing, process development, or quality assurance) in in Biotech or pharmaceutical industry with progressively increasing responsibility and demonstrated experience in compliance, problem solving, advance root cause analysis, critical thinking, project management, and quality systems.
  • Thorough understanding of quality management systems and quality control processes related to Raw Materials utilization in clinical and commercial operations.
  • Thorough working knowledge of owning deviations, CAPAs, CAPA-EVs and change controls
  • Demonstrated ability to work autonomously, present data in an organized and logical manner, and communicate effectively
  • Demonstrated ability to navigate through ambiguity and provide a structured problem-solving approach.
  • Excellent interpersonal relationship skills.
  • Excellent oral and written communication skills.
  • Proficient with TrackWies; Word; Excel; PowerPoint

Job Requirements

Preferred Qualifications:

  • 6+ years related work experience (manufacturing, process development, or quality assurance) in in Biotech or pharmaceutical industry with progressively increasing responsibility and demonstrated experience in compliance, problem solving, advance root cause analysis, critical thinking, project management, and quality systems.
  • Thorough understanding of quality management systems and quality control processes related to Raw Materials utilization in clinical and commercial operations.
  • Thorough working knowledge of owning deviations, CAPAs, CAPA-EVs and change controls
  • Demonstrated ability to work autonomously, present data in an organized and logical manner, and communicate effectively
  • Demonstrated ability to navigate through ambiguity and provide a structured problem-solving approach.
  • Excellent interpersonal relationship skills.
  • Excellent oral and written communication skills.
  • Proficient with TrackWies; Word; Excel; PowerPoint
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