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QC Analyst II

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Job Summary

Developing professional expertise, applies company policies and procedures to resolve a variety of issues. Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors. Exercises judgment within defined procedures and practices to determine appropriate action. Builds productive internal/external working relationships.

Responsibilities

  • Provide timely analyses to support manufacturing and stability. This includes routine analyses of raw materials, in process and release of commercial product or clinical supplies
  • Independently perform assays under GMP, maintaining data integrity and ensuring compliance with company SOPs and specifications
  • Provide accurate, written documentation of all work, including detailed observations and conclusions.
  • Under general guidance, participate in laboratory investigations
  • Independently operate, maintain and troubleshoot laboratory instrumentation and equipment in a safe working environment

Skills required

  • Well-organized, capable of multi-tasking, and able to collaborate with individuals in a matrix environment
  • Extensive hands-on experience performing relevant analytical techniques (HPLC, GC, FTIR). Experience with EMPOWER a plus
  • Must have excellent data analysis skills with attention to detail and interpretation of results with a focus on problem solving
  • Excellent written, oral communication skills, and experience with computer software such as WORD, EXCEL, etc.
  • Knowledge of validation requirements for QC methods and regulatory guidelines

    Education and Experience Minimum Requirements

    • Bachelor’s Degree in science or related field
    • 2-5 years relevant experience in a cGMP pharmaceutical QC environment, or at least 1 year with a Master’s degree

    Physical Requirements

    • Prolonged periods of sitting at a desk and working on a computer
    • Potentially prolonged periods standing
    • Must be able to lift up to 15 pounds at times
    • Must be willing to travel

    Compensation

    The base salary for this role starts at $41/hour. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, and relevant education or training. Our compensation package also includes diverse health and other benefits and an annual target bonus for full-time positions.