Job Description

QRC Group, LLC is a firm dedicated to offer services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields.

Log on now to our website http://www. qrcgroup.com to learn more about our services and solutions!

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.

Qualifications

• 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)

Additional Information

All your information will be kept confidential according to EEO guidelines.