Manufacturing & Quality Systems Specialist

Quality Consulting Group, LLC; Juncos (PR); On-site; USD 75,000 - 110,000; Full time

Job summary

Quality Consulting Group, LLC in Puerto Rico/USA is seeking a talented quality manufacturing specialist to join our team. You’ll work with a highly enthusiastic team, contributing to a world-class manufacturing industry in Puerto Rico & USA.

You will support manufacturing/quality systems, manage deviations, change controls, CAPA investigations, risk assessments, and training material development while collaborating across functions. Prior experience with TrackWise is a plus.

Qualifications

• Bachelor’s degree in Life Sciences, Biology, Chemistry, and/or Engineering.
• Engineering degree is a plus.
• Deviations management required.
• Deviation assessments required.
• Previous experience with TrackWise.
• Biotech and manufacturing experience.

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 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.

Skills

Process ownership

Deviation management

Root Cause Analysis

Troubleshooting

Training materials development

Education

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

Engineering degree is a plus

Tools

TrackWise

Job description

Quality Consulting Group, LLC in Puerto Rico/USA is seeking a talented quality manufacturing specialist to join our team. You’ll work with a highly enthusiastic team, contributing to a world-class manufacturing industry in Puerto Rico & USA.

You will support manufacturing/quality systems, manage deviations, change controls, CAPA investigations, risk assessments, and training material development while collaborating across functions. Prior experience with TrackWise is a plus.