JT937 - SPECIALIST MANUFACTURING

QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing to a world-class manufacturing industry in Puerto Rico & USA.

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
• May serve as primary production process owner for process support systems and assist with process ownership responsibilities on more complex process systems
• Own change controls for manufacturing process changes
• Support major/trend deviation investigations throughout the whole lifecycle including Root Cause Analysis investigation, determination of Corrective/Preventive Actions, authoring process investigation reports, and presenting within regulatory inspections
• Support Risk Assessments exercises and Microbial assessment evaluations
• Led commercial campaign readiness and effectively communicate and collaborate with cross function areas
• Assist in the generation of training materials and assist in providing training on scientific or technical aspects of the process
• Provide commercial support when needed and assist on the floor troubleshooting
• Design, coordinate, and support execution of functional tests, water tests, and other runs to challenge process and operations during major changes, or campaign readiness. Generate technical protocols as needed
• Assist and provide guidance during MBR (Master Batch Record) creation/revisions
• Perform assessment to support process, automation, or equipment modification or implementation of special projects
• Initiate, revise, and approve standard manufacturing procedures. Ensure all procedures reflect current operations. Serve as a document owner
• Assess process performance and review of performance data. Evaluate, plan, and implement solutions for process improvement opportunities
• Complete assessments for CAPA applicability requests from other plants/sites
• Complete assessment for new or changes in BOM's (Bill of Materials)
• Serves as a peer-recognized specialist in at least one area, with overall responsibility for determining methodologies in that area.

Qualifications:
• Bachelor's degree in Life Sciences, Biology, Chemistry, and/or Engineering.
• Experience providing on-floor manufacturing support and assessing process performance through operational observations and performance data analysis.
• Experience initiating, revising, reviewing, and approving manufacturing procedures.
• Knowledge of manufacturing process troubleshooting and issue resolution.
• Experience participating in New Product Introduction (NPI) activities, including documentation, material, and training assessments.
• Familiarity with Change Control processes and preparation or review of CCRB packages.
• Experience supporting special projects, process improvements, and manufacturing initiatives
• Non Standard Shift