Manufacturing Specialist – Pharmaceutical & Biotech

About the role

Quality Consulting Group is seeking a Manufacturing Specialist to support its pharmaceutical, biotech and medical‑device manufacturing sites in Puerto Rico and the United States. The role will collaborate with cross‑functional teams to ensure product quality, regulatory compliance and efficient production.

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 major/trend deviation investigations, perform root‑cause analysis, define corrective and preventive actions, and present findings during regulatory inspections.
• Conduct risk assessments, microbial assessments and support commercial campaign readiness.
• Develop and deliver training materials on scientific and technical aspects of processes.
• Design, coordinate and execute functional, water and other qualification tests during major changes or campaign readiness.
• Create and revise Master Batch Records (MBR) and standard manufacturing procedures, serving as document owner.
• Assess process performance, evaluate data, and implement process improvement solutions.
• Provide expertise for CAPA applicability, bill‑of‑materials changes and special projects involving automation or equipment modifications.

Required profile

• Bachelor’s degree in Life Sciences, Biology, Chemistry or Engineering.
• Extensive experience in bio‑processing unit operations such as cell culture and drug substance purification.
• Proven experience conducting root‑cause analysis and managing deviation investigations throughout product lifecycle.
• Familiarity with regulatory environments in pharmaceutical/biotech manufacturing.

Required skills

• Cell culture operations
• Drug substance purification
• Root‑cause analysis methodologies (Fishbone, 5 Why’s, Kepner‑Tregoe, etc.)
• Process validation and change control
• CAPA management
• Master Batch Record (MBR) creation and revision
• Risk assessment and microbial assessment
• Functional and water testing design
• Standard operating procedure authoring