Quality Consulting Group, LLC
Overview
QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.
Responsibilities
Evaluate the impact of validated computerized systems on existing work instructions and processes.
Prepare and execute computer system validation protocols and generate comprehensive reports.
Develop and maintain
Installation Qualification (IQ) documentation.
Collaborate with process owners to implement changes to work instructions and ensure compliance.
Inspect machinery, equipment, and tools to verify performance and initiate corrective actions as needed.
Ensure adherence to company procedures, quality system regulations, and industry standards.
Apply technical expertise and knowledge of engineering practices to optimize equipment and manufacturing techniques.
Organize and track project progress, maintaining detailed documentation and status updates.
Contribute to cross-functional projects and support milestone completion.
Communicate effectively with internal stakeholders to share updates, gather input, and support decision-making.
Qualifications
Bachelor’s degree in Engineering
Minimum of 3 years of relevant experience, or an advanced degree with 0 years of experience
Practical knowledge and demonstrated competence in validation and quality systems
Investigation and root cause analysis skills
Technical writing knowledge
Organization and Communication skills
Process Validation and Computer software validation knowledge
Experience in SDLC
Experience in medical devices or other highly regulated industry( e.g., medical devices, pharmaceuticals, biotech )
Excellent verbal and written communication skills in both English and Spanish
Availability to work 1st shift
Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
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Responsibilities
Evaluate the impact of validated computerized systems on existing work instructions and processes.
Prepare and execute computer system validation protocols and generate comprehensive reports.
Develop and maintain
Installation Qualification (IQ) documentation.
Collaborate with process owners to implement changes to work instructions and ensure compliance.
Inspect machinery, equipment, and tools to verify performance and initiate corrective actions as needed.
Ensure adherence to company procedures, quality system regulations, and industry standards.
Apply technical expertise and knowledge of engineering practices to optimize equipment and manufacturing techniques.
Organize and track project progress, maintaining detailed documentation and status updates.
Contribute to cross-functional projects and support milestone completion.
Communicate effectively with internal stakeholders to share updates, gather input, and support decision-making.
Qualifications
Bachelor’s degree in Engineering
Minimum of 3 years of relevant experience, or an advanced degree with 0 years of experience
Practical knowledge and demonstrated competence in validation and quality systems
Investigation and root cause analysis skills
Technical writing knowledge
Organization and Communication skills
Process Validation and Computer software validation knowledge
Experience in SDLC
Experience in medical devices or other highly regulated industry( e.g., medical devices, pharmaceuticals, biotech )
Excellent verbal and written communication skills in both English and Spanish
Availability to work 1st shift
Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
#J-18808-Ljbffr