JT599 - SPECIALIST MANUFACTURING

Quality Consulting Group, LLC; Juncos (PR); On-site; USD 85,000 - 115,000; Full time

Job summary

Quality Consulting Group, LLC in Puerto Rico and the USA seeks a talented quality systems professional to join our team. You’ll support bioprocessing manufacturing operations, contribute to world-class manufacturing practices, and work with cross-functional teams across regions.

You will own change controls, assist with CAPA investigations, and help develop procedures and training materials in a regulated environment. Flexibility for extended hours may be required.

Qualifications

• Bachelor's degree in Life Sciences, Biology, Chemistry, or Engineering.
• Experience in bioprocessing unit operations.
• Knowledge of RCA methodologies (Fishbone/Ishikawa, 5 Whys, Kepner-Tregoe).
• Familiarity with Lean Manufacturing principles and continuous improvement practices.
• Proficiency in GDP/GMP within a regulated manufacturing environment.
• Strong English and Spanish communication skills.

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 Root Cause Analysis, determination of CAPA, and presenting within regulatory inspections.
• Assist in risk assessments and microbial assessment evaluations.
• Lead commercial campaign readiness and collaborate with cross-functional areas.
• Assist in training material generation and delivery of training on scientific/technical aspects.

Skills

RCA methodologies

Lean manufacturing

GDP / GMP familiarity

English & Spanish fluency

Cross-functional collaboration

Communication skills

Education

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

Tools

TrackWise

Veeva

MES

Smartsheet

Power BI

Spotfire

CDOCS

ChatGPT

Microsoft Copilot

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.