Bioprocess Quality & Process Systems Specialist

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, 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.