Manufacturing Quality & Process Excellence Specialist

Quality Consulting Group, LLC; Juncos (PR); On-site; USD 70,000 - 100,000; Full time

Job summary

QUALITY CONSULTING GROUP, LLC is seeking a talented, highly motivated manufacturing quality engineer to join our team in Puerto Rico/USA. The role focuses on supporting manufacturing and quality systems within regulated environments.

You will work with cross-functional teams to drive process improvements, CAPA actions, and document control while ensuring compliance with cGMP standards and regulatory expectations.

Qualifications

• Bachelor's degree in a related engineering field.
• Hands-on manufacturing operations experience in regulated environments (biotech/pharma).
• Familiarity with automation, process equipment, and continuous improvement methods.

Responsibilities

• Support the execution of manufacturing/quality systems (non-conformances, process validation, procedures, training, and new product introductions).
• Apply process knowledge to support manufacturing operations and troubleshoot issues.
• Own change controls for manufacturing process changes and support investigations (CAPA, root cause).
• Lead risk assessments and microbial assessment evaluations as needed.
• Assist in generation of training materials and provide on-floor training.
• Design, coordinate, and support functional tests and protocol generation.

Skills

Engineering experience

Automation systems

Process equipment

Lean Six Sigma

Kaizen

Root cause analysis

Problem solving

CAPA

Process optimization

Cross-functional collaboration

GMP knowledge

Communication

Adaptability

Shift flexibility

Education

Bachelor's degree in related area (Engineering preferred: Chemical, Mechanical, Industrial, or Biotechnology)

Job description

QUALITY CONSULTING GROUP, LLC is seeking a talented, highly motivated manufacturing quality engineer to join our team in Puerto Rico/USA. The role focuses on supporting manufacturing and quality systems within regulated environments.

You will work with cross-functional teams to drive process improvements, CAPA actions, and document control while ensuring compliance with cGMP standards and regulatory expectations.