JT599 - SPECIALIST MANUFACTURING

Quality Consulting Group • Juncos, PR

6d

About The Position

Quality Consulting Group is seeking a motivated Specialist Manufacturing to support pharmaceutical, biotech, medical device, and manufacturing operations in Puerto Rico and the USA. The role applies process, operational, and scientific expertise to manufacturing and quality systems, supports process troubleshooting and continuous improvement, and contributes to compliance activities in a regulated manufacturing environment. The specialist may serve as the primary production process owner for process support systems and is responsible for determining methodologies in at least one area of recognized expertise.

The position supports manufacturing changes, investigations, validation, training, product introductions, campaign readiness, documentation, and process performance assessments. It collaborates with Manufacturing, Process Development, Quality, and other cross-functional teams, and may require extended hours or overtime based on business needs.

Requirements

• Bachelor's degree in Life Sciences, Biology, Chemistry, and/or Engineering.
• Experience in bioprocessing unit operations.
• Knowledge of root cause analysis 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 in 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.

Responsibilities

• Support manufacturing and quality systems, including non-conformances, process validation, procedures, training, and new product introductions.
• Apply process, operational, and scientific expertise, compliance knowledge, and analytical and troubleshooting skills to support manufacturing operations.
• Serve as primary production process owner for process support systems when assigned, and assist with ownership responsibilities for more complex systems.
• Own change controls for manufacturing process changes.
• Support major and trend deviation investigations through the full lifecycle, including root cause analysis, corrective and preventive action determination, investigation report authoring, and presentation during regulatory inspections.
• Support risk assessment exercises and microbial assessment evaluations.
• Lead commercial campaign readiness and collaborate and communicate with cross-functional areas.
• Assist in generating training materials and provide training on scientific or technical aspects of processes.
• Provide commercial support and on-floor troubleshooting as needed.
• Design, coordinate, and support functional tests, water tests, and other runs to challenge processes and operations during major changes or campaign readiness; generate technical protocols as needed.
• Assist with and provide guidance during Master Batch Record creation and revisions.
• Assess process, automation, or equipment modifications and implementations, as well as special projects.
• Initiate, revise, and approve standard manufacturing procedures; ensure procedures reflect current operations and serve as a document owner.
• Assess process performance and review performance data; evaluate, plan, and implement process improvement solutions.
• Complete assessments for CAPA applicability requests from other plants or sites.
• Assess new or changed Bills of Materials.
• Determine methodologies in at least one area as a peer-recognized specialist.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level