Manufacturing Quality Specialist: Change Controls Lead

Quality Consulting Group, LLC; Juncos (PR); On-site; USD 90,000 - 120,000; Full time

Job summary

Quality Consulting Group, LLC is seeking a highly motivated teammate to join our manufacturing quality team in Puerto Rico and the USA. You will support quality systems, manage change controls, and contribute to process validation, investigations, and CAPA activities.

Responsibilities include developing training materials, participating in risk assessments, and aiding in campaigns with cross-functional teams.

Qualifications

• : Bachelor’s degree in Life Sciences, Biology, Chemistry, and/or Engineering.
• : Knowledge of document management within Veeva Vault (CDOCs) or similar platforms.
• : Strong technical writing skills.
• : Experience handling change controls as the owner.
• : Proven project management experience.
• : Proficiency in Smartsheet or similar project management platforms.

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 including Root Cause Analysis, CAPA actions, and regulatory inspection readiness.
• Assist in risk assessments and microbial assessment evaluations.
• Lead campaign readiness and collaborate with cross-functional areas.
• Generate training materials and provide training on process-related topics.
• Provide on-floor troubleshooting and commercial support when needed.
• Design, coordinate, and support functional/ water tests and other runs during major changes.

Skills

Documentation writing

Project management

SMartsheet

Quality systems

Education

Bachelor's degree in Life Sciences, Biology, Chemistry, and/or Engineering

Tools

Veeva Vault/CDOCs

Job description

Quality Consulting Group, LLC is seeking a highly motivated teammate to join our manufacturing quality team in Puerto Rico and the USA. You will support quality systems, manage change controls, and contribute to process validation, investigations, and CAPA activities.

Responsibilities include developing training materials, participating in risk assessments, and aiding in campaigns with cross-functional teams.