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JT451 - SPECIALIST MANUFACTURING

Quality Consulting Group

Juncos

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JOB DETAILS
SKILLS
Analysis Skills, Biology, Biotech and Pharmaceutical, Change Control, Chemistry, Communication Skills, Consulting, Continuous Improvement, Corrective Action, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Data Processing, Documentation, English Language, Identify Issues, Investigative Reports, Lean Manufacturing, Manufacturing, Manufacturing Operations, Manufacturing Systems, Manufacturing/Industrial Processes, Materials Analysis, Medical Equipment, Operational Support, Operations Processes, Power BI, Presentation/Verbal Skills, Process Analysis, Process Development, Process Improvement, Process Validation, Product Support, Product/Service Launch, Regulations, Reporting Skills, Root Cause Analysis, Spanish Language, Systems Analysis, Team Player, Technical Leadership, Technical Support, Technical Writing, Tibco Spotfire, Trend Analysis, Writing Skills
LOCATION
Juncos
POSTED
6 days ago
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.
  • Initiate, revise, and approve manufacturing procedures, ensuring all documentation reflects current operations and serving as a document owner.
  • Evaluate, plan, and implement process improvement initiatives to enhance manufacturing efficiency and compliance.
  • Provide technical troubleshooting support for manufacturing processes and equipment-related issues.
  • Assist in the development of training materials and support training activities on scientific and technical process aspects.
  • Collect, analyze, and evaluate process monitoring data to identify trends and support deviation assessments.
  • Ensure non-conformances are triaged within established timelines and quality goals.
  • Author investigation reports related to deviations, non-conformances, and process events.
  • Execute corrective and preventive actions (CAPAs) and support their implementation.
  • Manage non-conformance and CAPA records through closure within established timelines.
  • Monitor, analyze, and communicate incident and deviation trends.
  • Review equipment and system Root Cause Analysis investigations and support trend evaluations.
  • Support the execution of process validation activities and associated documentation.
  • Participate in regulatory inspections and support compliance-related activities.
  • Support New Product Introductions (NPI) by assessing documentation, materials, training, and equipment modification requirements.
  • Assist manufacturing change owners with Change Control Review Board (CCRB) packages impacting manufacturing processes.
  • Participate in special projects, continuous improvement initiatives, and cross-functional operational activities.
Qualifications:
  • Bachelor's degree in Life Sciences, Biology, Chemistry, and/or Engineering.
  • Experience of bio-processing unit operations
  • Knowledge in Root Cause Analysis methodologies (Fishbone, Six Boxes, Fishbone, 5 Why’s, Kepner Tregoe)
  • Familiar with Lean Manufacturing Practices
  • Ability to communicate and collaborate with technical and management staff within manufacturing, process development, and quality.
  • Proficiency in GDP (Good Documentation Practices) on a regulated environment
  • Knowledge in systems/Tools: Trackwise, VEEVA, MES, Smart Sheet, ChatGPT, Copilot, Power BI, Spotfire, CDOCS, and process monitoring platforms
  • Strong Technical Writing/presentation abilities, and excellent written/verbal communication skills in English and Spanish
  • Teamwork Oriented
  • Able to work under minimal supervision and/or high workload and pressure
  • Able to work extended hours
  • Administrative Shift 

Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

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Quality Consulting Group

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