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Phil Ellis Associates jobs

Viewing 11 - 19 of 23 jobs

  • Sr. Manager, Regulatory Affairs #002

    Phil Ellis Associates - Raleigh, NC

    JOB DESCRIPTION US Agent for the company to the Agency. Maintenance of company's Drug Establishment Registrations (DER) covering all sites. Drug Listing, Create NDC numbers. Provide information on GDUFA requirements and GDUFA fees. Major...

    21 days ago from TalentDesk

  • Quality Engineering Manager

    Phil Ellis Associates - San Francisco, CA

    Job Description Participate in the development of new processes, issue resolution, and manufacturing design review transfers. • Supervise and approve investigations relating to root cause of customer complaints and deviations, and propose...

    1 day ago from Phil Ellis Associates, Inc.

  • Director, Method Validation

    Phil Ellis Associates - San Francisco, CA

    Job Description The Director of Method Validation is responsible for providing the day to day leadership and analytical chemistry and regulatory guidance to the Method Validation and Method Transfer sections of R&D Analytical Sciences. The...

    1 day ago from Phil Ellis Associates, Inc.

  • Manager, CMC Regulatory Affairs

    Phil Ellis Associates - San Francisco, CA

    to maintain such documents. -Assist other department associates in the preparation of regulatory submissions as necessary to manage department workload. -Review regulatory CMC submissions prepared by junior staff. -Advise cross-functional...

    1 day ago from Phil Ellis Associates, Inc.

  • Validation Specialist

    Phil Ellis Associates - St Louis, MO

    Job Description -Prepare and execute cleaning, process and packaging validation, and equipment qualification plans and protocols. -Write Final Summary Reports that summarize executed qualifications/validations. -Assist in the development,...

    1 day ago from Phil Ellis Associates, Inc.

  • Regulatory Affairs Director

    Phil Ellis Associates - Charlotte, NC

    Job Description JOB SUMMARY: This position is responsible for directing and managing the Regulatory and Compliance functions within the organization. The Director will provide direction on product labeling claims, maintain appropriate...

    1 day ago from Phil Ellis Associates, Inc.

  • Validation Manager

    Phil Ellis Associates - St Louis, MO

    Job Description -Manage day-to-day validation operations for cleaning, process and packaging validation, and equipment qualification plans and protocols. -Create, review and implement cleaning, process and packaging validation, and...

    1 day ago from Phil Ellis Associates, Inc.

  • Computer Validation Specialist

    Phil Ellis Associates - St Louis, MO

    Job Description -Prepare and perform computer related (i.e., software, hardware) qualification/validation protocols. -Develop and execute computer validation protocols for database applications, automated utility systems, automated...

    1 day ago from Phil Ellis Associates, Inc.

  • Director, Regulatory Affairs

    Phil Ellis Associates - San Francisco, CA

    Job Description Train and mentor staff on company procedures and FDA guidances to insure appropriate knowledge base to support teams. Aid in the establishment of processes and procedures to insure company staff are in compliance with...

    1 day ago from Phil Ellis Associates, Inc.