Manufacturing Quality Specialist: Change Control & CAPA

Quality Consulting Group, LLC; Juncos (PR); On-site; USD 80,000 - 120,000; Full time

Job summary

Quality Consulting Group, LLC is a leading provider in pharmaceutical, biotech, medical devices, and manufacturing sectors, seeking a highly motivated team member in Puerto Rico and the USA. The role covers supporting manufacturing quality systems, change controls, CAPA investigations, and risk assessments, with emphasis on document editing and process ownership.

Collaborative work with cross-functional teams is expected, ensuring compliance and continuous improvement.

Qualifications

• Experience with CAPA management, Change Controls (CC), Risk Assessments, and CDOC document editing.

Responsibilities

• Support execution of quality systems and CAPA processes.
• Own change controls for manufacturing process changes.
• Assist in risk assessments and investigations across lifecycle stages.
• Prepare, review, and revise procedures and batch records as needed.
• Provide training materials and support on technical processes.

Skills

CAPA management

Change Controls

Risk Assessments

CDOC editing

Education

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

Job description

Quality Consulting Group, LLC is a leading provider in pharmaceutical, biotech, medical devices, and manufacturing sectors, seeking a highly motivated team member in Puerto Rico and the USA. The role covers supporting manufacturing quality systems, change controls, CAPA investigations, and risk assessments, with emphasis on document editing and process ownership.

Collaborative work with cross-functional teams is expected, ensuring compliance and continuous improvement.