JT599 - SPECIALIST MANUFACTURING

Quality Consulting Group, LLC; Juncos (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

Quality Consulting Group, LLC is seeking a highly motivated professional to join our team in Puerto Rico and the USA. The role focuses on supporting manufacturing/quality systems, change controls, and CAPA investigations across multiple sites.

Strong RCA, Lean, and documentation skills are essential, with bilingual English/Spanish communication expected across teams. The position involves collaboration with Manufacturing, Process Development, and Quality groups, with opportunities to influence

Qualifications

• Bachelor's degree in Life Sciences, Biology, Chemistry, or Engineering.
• Experience in bioprocessing unit operations.
• Knowledge of RCA methodologies (Fishbone, 5 Whys, Ishikawa, Kepner-Tregoe).
• Familiarity with Lean Manufacturing and continuous improvement.
• GDP knowledge in regulated manufacturing environments.
• Experience with TrackWise, Veeva, MES, Smartsheet and monitoring platforms.

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 and analytical skills to support manufacturing operations.
• Own change controls for manufacturing process changes.
• Support investigations for CAPA and root cause analyses across lifecycle.
• Lead cross-functional campaigns and assist on floor troubleshooting as needed.
• Design and coordinate functional tests and training materials for process changes.
• Assist in Master Batch Records (MBR) creation/revisions and documentation control.

Skills

Root Cause Analysis

Lean Manufacturing

Cross-functional collaboration

Documentation skills

Bilingual English/Spanish

Education

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

Tools

TrackWise

Veeva

MES

Smartsheet

Power BI

ChatGPT

Microsoft Copilot

CDOCS

Job description

QUALITY CONSULTING GROUP, a leader inthe 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 in bioprocessing unit operations.
• Knowledge of Root Cause Analysis (RCA) methodologies, including Fishbone (Ishikawa Diagram), Six Boxes, 5 Whys, and Kepner-Tregoe.
• Familiarity with Lean Manufacturing principles and continuous improvement practices.
• Ability to communicate and collaborate effectively with technical and management personnel across Manufacturing, Process Development, and Quality organizations
• Proficiency in Good Documentation Practices (GDP) within a regulated manufacturing environment
• Experience using systems and tools such as TrackWise, Veeva, MES, Smartsheet, ChatGPT, Microsoft Copilot, Power BI, Spotfire, CDOCS, and process monitoring platforms
• Strong technical writing and presentation skills, with excellent verbal and written communication abilities in both English and Spanish
• Team-oriented with the ability to work effectively in cross-functional environments
• Ability to work independently with minimal supervision and perform effectively under high workload and pressure
• Willingness to work extended hours as required to support business and operational needs
• Excellent interpersonal and relationship-building skills
• Shift: M-F | 8am to 5pm | OT may be requested based on business needs.