Senior Scientist - Quality Control

Weil Group•Barceloneta, PR

About The Position

Performs laboratory testing in a GMP environment in support of one or more areas: raw materials, in-process product, finished product, stability, and/or validation. Uses scientific education and/or experience to generate results in accordance with GMP and procedural requirements and scientific principles. Interprets data to determine whether results conform to product specifications and reviews and verifies data generated by others for conformance. Understands internal business processes to prioritize assigned work. Has command of multiple laboratory techniques, performs them with minimal error, and can train laboratory personnel on techniques included in their training matrix.

Requirements

  • Bachelor’s degree in science, preferably Microbiology, Biology, Chemistry, or Biochemistry, and 6 years of experience in a related field; or a master’s degree in science in a preferred field and 4 years of related experience; or a PhD in science in a preferred field and 2 years of related experience.
  • Manage multiple priorities and comply with deadlines.
  • Maintain certifications as needed for assigned job tasks.
  • Demonstrate strong analytical skills and a logical thought process.

Responsibilities

  • Understand, implement, and maintain GMP requirements for laboratory records, procedures, and systems.
  • Propose and implement changes to maintain procedural requirements.
  • Perform analytical test methods as written to support product or material release with minimal error.
  • Propose and implement improvements to laboratory techniques and methodology.
  • Independently troubleshoot and resolve analytical technique and instrument issues.
  • Interpret experimental data to determine conformance with product and material specifications.
  • Assess laboratory technique and instrument performance in accordance with scientific principles.
  • Initiate appropriate exception documents in accordance with procedural requirements.
  • Implement and ensure completion of improvement ideas to facilitate team objectives.
  • Propose and implement scientific protocols to determine the cause of exception events.
  • Train other laboratory personnel on techniques in the employee’s training matrix.
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