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:
- Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.
- Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
- Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
- Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
- Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
- May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.
- Equipment & Process Validation
- Quality Systems & Change Control
- Regulatory Compliance & Manufacturing Change Management
Qualifications:
- Bachelor's degree in engineering
- 4+ years of experience in related area
- Expertise in developing, reviewing, approving and executing validation strategies and deliverables associated with equipment qualification (IQ/CSV/OQ/PQ), equipment decommissioning, process validation, cleaning validation, and cleanroom qualification activities in GMP-regulated environments.
- Strong knowledge of Quality Management Systems (QMS), including change control, risk management, nonconformance investigations, and assessment of quality impact resulting from equipment, facility, and process changes.
- Experience evaluating regulatory impact associated with facility modifications, equipment relocations, and process changes, ensuring compliance with FDA, ISO 13485, and applicable global regulatory requirements.
- Strong expertise in equipment and process validation (IQ/OQ/PQ), including requalification for new, modified, or relocated equipment
- Experience supporting equipment purchases, relocations, and decommissioning with full quality and compliance oversight
- Experience ensuring audit-ready documentation and compliance with internal and regulatory requirements
- Availability for 1st shift
Skills Required
- Bachelor's degree in engineering
- 4+ years of experience in related area
- Expertise in developing, reviewing, approving and executing validation strategies and deliverables (equipment qualification IQ/CSV/OQ/PQ, decommissioning, process validation, cleaning validation, cleanroom qualification) in GMP environments
- Strong knowledge of Quality Management Systems (QMS), including change control, risk management, and nonconformance investigations
- Experience evaluating regulatory impact for facility modifications, equipment relocations, and process changes; knowledge of FDA, ISO 13485, and global regulatory requirements
- Expertise in equipment and process validation (IQ/OQ/PQ) including requalification for new, modified, or relocated equipment
- Experience supporting equipment purchases, relocations, and decommissioning with full quality and compliance oversight
- Experience ensuring audit-ready documentation and compliance with internal and regulatory requirements
- Availability for 1st shift
What We Do
The Quality Consulting Group is a pharmaceutical, biotechnology, food and medical device specialty consultant that supports the manufacturing industry; services are provided in multiple areas including: Regulatory Compliance, Quality Operations, Validation, Manufacturing, Training and Technical Support. Starting, as individual services provider since 2002, Quality Consulting Group has supported clients implementing the latest standards such as Validation Guidance, ICH Guidelines, and Process Excellence and Risk Management tools. Quality Consulting Group has provided expertise in such areas as: business, operational, quality, regulatory and manufacturing strategies; organizational structures; management controls; manufacturing and quality systems methodologies and practices; compliance programs; and accuracy reviews; FDA, EMEA and other regulatory matter
