Manufacturing Specialist (JT599)

About the role

Quality Consulting Group is seeking a motivated Manufacturing Specialist to support its pharmaceutical, biotech, and medical device manufacturing sites in Puerto Rico and the United States. You will work with a dynamic team to ensure high‑quality production, compliance, and continuous improvement across multiple processes.

Key responsibilities

• Support execution of manufacturing and quality systems, including non‑conformances, process validation, procedures, training, and new product introductions.
• Own change controls for manufacturing process changes and serve as primary production process owner for complex systems.
• Lead deviation investigations, root‑cause analysis, corrective/preventive actions, and present findings during regulatory inspections.
• Conduct risk assessments, microbial evaluations, and support commercial campaign readiness.
• Develop and deliver training materials, provide on‑floor troubleshooting, and generate technical protocols.
• Assist in Master Batch Record (MBR) creation/revisions and approve standard manufacturing procedures.
• Assess process performance, drive improvement projects, and evaluate CAPA applicability.

Required profile

• Bachelor’s degree in Life Sciences, Biology, Chemistry, Engineering, or related field.
• Experience in bioprocessing unit operations and manufacturing environments.
• Strong knowledge of root‑cause analysis methodologies (Fishbone, 5 Whys, Kepner‑Tregoe, etc.).
• Familiarity with Lean Manufacturing and continuous‑improvement practices.
• Ability to communicate effectively with technical and management teams across Manufacturing, Process Development, and Quality.

Required skills

• Root Cause Analysis
• Lean Manufacturing
• Good Documentation Practices
• Bioprocessing operations
• Process Validation