Quality Change-Control Specialist for GMP Manufacturing

Quality Consulting Group, LLC; Juncos (PR); Hybrid; USD 90,000 - 120,000; Full time

Job summary

Quality Consulting Group, LLC is seeking a talented quality engineer to join our team in Puerto Rico and the USA, supporting manufacturing quality systems and change controls. You will own change controls, assist with CAPA investigations, prepare technical protocols and ensure documentation accuracy across supplier-related records.

The role emphasizes cross-functional collaboration, tracking quality metrics, and maintaining compliance with cGMP and regulatory expectations in a fast-paced

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Chemistry, Microbiology, or a related scientific discipline.
• Experience in the pharmaceutical, biotechnology, or medical device industry within a cGMP-regulated environment.
• Strong knowledge and hands-on experience with Change Control processes and quality systems.
• Experience serving as a Quality Record Owner or managing supplier-related Change Control quality records.
• Proficiency in TrackWise for creating, managing, and closing quality records.
• Working knowledge of SAP for supplier-related quality documentation and record management.
• Demonstrated critical-thinking and risk assessment skills to evaluate supplier-related quality records and drive compliant decisions.
• Experience leading and facilitating cross-functional meetings to ensure timely execution and closure of Change Control records.
• Strong organizational, communication, and collaboration skills with the ability to work across multiple stakeholders.
• Ability to manage multiple priorities, meet deadlines, and work independently with minimal supervision.
• Proficiency in written and verbal English; bilingual English/Spanish is preferred.
• Administrative Shift

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.

Skills

Change control processes

Quality systems

Quality records ownership

TrackWise

SAP

Cross-functional leadership

Risk assessment

English/Spanish bilingual

Strong communication

Independent work

Education

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

Tools

TrackWise

SAP

Job description

Quality Consulting Group, LLC is seeking a talented quality engineer to join our team in Puerto Rico and the USA, supporting manufacturing quality systems and change controls. You will own change controls, assist with CAPA investigations, prepare technical protocols and ensure documentation accuracy across supplier-related records.

The role emphasizes cross-functional collaboration, tracking quality metrics, and maintaining compliance with cGMP and regulatory expectations in a fast-paced