Bioprocess Quality Specialist — Process & Change Leader

Quality Consulting Group, LLC; Juncos (PR); Vor Ort; USD 85.000 - 110.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

RCA methodologies

Lean manufacturing

Technical writing

English/Spanish

Ausbildung

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

Tools

TrackWise

Veeva

MES

Smartsheet

ChatGPT

Microsoft Copilot

Power BI

Spotfire

CDOCS

Jobbeschreibung

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.