QRC Group, LLC

Process Development Principal Scientist

QRC Group, LLC  •  Juncos, PR (Onsite)  •  5 days ago
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Job Description


We are seeking a Process Development Principal Scientist to support all phases of inspection project management—from planning and implementation to monitoring, completion, and follow-up—ensuring alignment with goals, timelines, and quality standards.


Responsibilities:

  • Lead PD related Project Management projects and activities, timelines and resources allocation.

  • Work in teams with multiple fields, including manufacturing, process engineering, maintenance, quality assurance, and validation to implement projects.

  • Support the development of comprehensive business cases including technical and financial requirements.

  • Identify potential project risks, schedule changes, or resource constraints. Develop and implement solutions to maintain scientific efficiency, quality, and client satisfaction.

  • Maintain strict adherence to domestic and international regulatory requirements, internal policies, and standard operating procedures throughout the project lifecycle.

  • Balance competing timelines and priorities, ensuring critical tasks are completed efficiently and project standards for quality and quantity are met.

  • Provide flexibility to support extended hours, non-standard shifts, and evolving project demands as needed.

  • Ensure activities follow cGMP procedures and are documented according to cGMP requirements including assigned training.

  • Independently evaluate, select and apply standard engineering techniques and procedures.

  • Perform assignments that have clear and specific objectives and require investigation of a limited number of variables.

  • Applies lean six sigma, operational excellence and continues improvement in assigned projects.

  • Prompt and regular attendance to workplace. Although main working hours are regular 8:00 am to 5:00 pm the candidate need the flexibility to support non-standard shift operations in a 7/24 format including extended hours and/or weekends as needed.

  • Meet specific project team goals and timelines.

  • Develop project plans and strategies for implementation working with project managers and SMEs.


Requirements


  • Doctorate PhD + 2 years of Scientific or Engineering experience or, Masters + 5 years of Scientific or Engineering experience, or Bachelors + 7 years of Scientific or Engineering experience.

  • Bilingual (English and Spanish, written and spoken)
  • QRC Group, LLC

    About QRC Group, LLC

    QRC group is a life science firm dedicated to provide services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields.

    Our services and solutions include:

    Process and Laboratory Investigation

    • Corrective and Preventive Action (CAPA)

    • Change Control

    • Training

    • Document Management Control

    • QA Laboratory

    • Methodology Transfer and Validation

    • Instrument Calibration

    • Validation and Training in Chromatographic Data Acquisition System

    • Cleaning Validation

    • Automation Engineering

    • Quality Systems

    Industry
    HR & Recruiting
    Company Size
    11-50 employees
    Headquarters
    Caguas, PR
    Year Founded
    2005
    Social Media