JT599 - SPECIALIST MANUFACTURING

Quality Consulting Group, LLC; Juncos (PR); On-site; USD 85,000 - 110,000; Full time

Job summary

Quality Consulting Group, LLC is seeking a Manufacturing Quality Specialist to support manufacturing/quality systems, change controls, CAPA, and process improvements across Puerto Rico and the USA.

You will collaborate across Manufacturing, Process Development and Quality, prepare technical documentation, and assist with investigations, training, and audits. Bilingual English/Spanish communication is expected.

Qualifications

• Bachelor's degree in Life Sciences, Biology, Chemistry, and/or Engineering.
• Experience in bioprocessing unit operations.
• Knowledge of RCA methodologies including Fishbone (Ishikawa), Six Boxes, 5 Whys, Kepner-Tregoe.
• Familiarity with Lean Manufacturing and continuous improvement practices.
• Proficiency in GDP within a regulated manufacturing environment.
• Experience with TrackWise, Veeva, MES, Smartsheet, Power BI, Spotfire, CDOCS and related tools.
• Strong English and Spanish written and spoken communication.

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 lifecycle including RCA, CAPA determinations, and investigative reports.
• Support Risk Assessments and Microbial assessment evaluations.
• Led campaign readiness and collaborate with cross-functional areas.
• Assist in generating training materials and provide training on scientific/technical aspects.
• Provide on-floor troubleshooting and commercial support when needed.
• Design, coordinate, and execute functional tests, water tests and other runs; generate technical protocols.
• Assist and guide MBR creation/revisions.
• Assess processes for automation or equipment modification and support special projects.
• Initiate, revise, and approve standard manufacturing procedures; maintain document ownership.
• Assess process performance, review data, and implement improvements.
• Complete CAPA and BOM assessments for other plants/sites.
• Serve as a specialist with ownership of methodologies in at least one area.

Skills

RCA methodologies

Lean manufacturing

Technical writing

English/Spanish

Education

Bachelor's degree Life Sciences/Biology/Chemistry/Engineering

Tools

TrackWise

Veeva

MES

Smartsheet

ChatGPT

Microsoft Copilot

Power BI

Spotfire

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.

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.