Manufacturing Quality Specialist & Change Owner

Quality Consulting Group, LLC; Juncos (PR); On-site; USD 80,000 - 110,000; Full time

Job summary

Quality Consulting Group, LLC invites a results-driven Quality/Manufacturing Assurance professional to join our Puerto Rico/USA team. You will support manufacturing quality systems, drive change controls, and lead investigations with a focus on cGMP compliance and process improvements.

You will develop training materials, ensure Electronic Batch Records alignment, participate in CAPA and regulatory inspections, and collaborate cross-functionally to optimize manufacturing processes and new

Qualifications

• Bachelor's degree in Life Sciences, Biology, Chemistry, and/or Engineering.
• Experience initiating, revising, approving, and maintaining manufacturing procedures, serving as the document owner and ensuring procedures accurately reflect current operations.
• Ability to assess process performance through floor observations and performance data analysis, and to identify, plan, and implement process improvement opportunities.
• Experience developing training materials and providing training on scientific and technical aspects of manufacturing processes.
• Knowledge of cGMP requirements and other applicable regulations, with the ability to ensure processes and procedures remain compliant.
• Ability to identify, assess, and mitigate process risks to ensure product safety, quality, and manufacturing efficiency.
• Experience maintaining and ensuring alignment of Electronic Batch Records (EBRs) with current manufacturing processes and supporting related training activities.
• Experience supporting the development and implementation of process validation protocols and reports.
• Ability to participate in regulatory inspections and provide technical support as required.
• Experience participating in New Product Introduction (NPI) activities, including assessment of documentation, materials, training, and equipment modification requirements.

Responsibilities

• Support the execution of manufacturing/quality systems such as non-conformances, process validation, procedures, training, and new product introductions.
• Apply process, operational, scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to support manufacturing operations.
• Own change controls for manufacturing process changes.
• Support major/trend deviation investigations throughout the lifecycle including Root Cause Analysis, CAPA, and regulatory inspections.
• Assist in the generation of training materials and provide training on scientific or technical aspects of the process.
• Provide commercial support when needed and assist on the floor troubleshooting.
• Design, coordinate, and support execution of functional tests and water tests to challenge process during major changes or campaign readiness.
• Assist and provide guidance during MBR creation/revisions.
• Initiate, revise, and approve standard manufacturing procedures; serve as a document owner.
• Assess process performance and implement solutions for process improvement.

Skills

Change Controls

GMP compliance

Root Cause Analysis

Training materials

Process validation

Documentation ownership

Quality systems

Cross-function collaboration

Education

Bachelor's degree in Life Sciences/Engineering

Tools

EBRs

CAPA tools

Job description

Quality Consulting Group, LLC invites a results-driven Quality/Manufacturing Assurance professional to join our Puerto Rico/USA team. You will support manufacturing quality systems, drive change controls, and lead investigations with a focus on cGMP compliance and process improvements.

You will develop training materials, ensure Electronic Batch Records alignment, participate in CAPA and regulatory inspections, and collaborate cross-functionally to optimize manufacturing processes and new