JT421 - SPECIALIST MANUFACTURING
Quality Consulting Group, LLCJuncos, 00777
Posted June 2, 2026
Full Time
About the Company
Quality Consulting Group, LLC is a specialized consultancy firm providing comprehensive services to pharmaceutical, biotechnology, food, and medical device industries. With expertise in regulatory compliance, quality operations, validation, training, and technical support, the company helps clients implement industry standards such as Validation Guidance, ICH Guidelines, and Process Excellence tools. Quality Consulting Group stands out by offering a wide range of services including quality management, risk management, staffing, and human resources, ensuring clients achieve operational excellence and regulatory compliance.
Job Description
Quality Consulting Group is looking for a talented and highly motivated specialist in manufacturing to join their team. The specialist will work with a highly enthusiastic team contributing to a world-class manufacturing industry in Puerto Rico & USA.
Requirements
- Support the execution of manufacturing/quality systems
- 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