JT632 - SPECIALIST MANUFACTURING

Quality Consulting Group, LLC; Juncos (PR); On-site; USD 80,000 - 110,000; Full time

Job summary

Quality Consulting Group, LLC invites a results-driven Quality/Manufacturing Assurance professional to join our Puerto Rico/USA team. You will support manufacturing quality systems, drive change controls, and lead investigations with a focus on cGMP compliance and process improvements.

You will develop training materials, ensure Electronic Batch Records alignment, participate in CAPA and regulatory inspections, and collaborate cross-functionally to optimize manufacturing processes and new

Qualifications

• Bachelor's degree in Life Sciences, Biology, Chemistry, and/or Engineering.
• Experience initiating, revising, approving, and maintaining manufacturing procedures, serving as the document owner and ensuring procedures accurately reflect current operations.
• Ability to assess process performance through floor observations and performance data analysis, and to identify, plan, and implement process improvement opportunities.
• Experience developing training materials and providing training on scientific and technical aspects of manufacturing processes.
• Knowledge of cGMP requirements and other applicable regulations, with the ability to ensure processes and procedures remain compliant.
• Ability to identify, assess, and mitigate process risks to ensure product safety, quality, and manufacturing efficiency.
• Experience maintaining and ensuring alignment of Electronic Batch Records (EBRs) with current manufacturing processes and supporting related training activities.
• Experience supporting the development and implementation of process validation protocols and reports.
• Ability to participate in regulatory inspections and provide technical support as required.
• Experience participating in New Product Introduction (NPI) activities, including assessment of documentation, materials, training, and equipment modification requirements.

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.
• Own change controls for manufacturing process changes.
• Support major/trend deviation investigations throughout the lifecycle including Root Cause Analysis, CAPA, and regulatory inspections.
• Assist in the generation of training materials and provide 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 and water tests to challenge process during major changes or campaign readiness.
• Assist and provide guidance during MBR creation/revisions.
• Initiate, revise, and approve standard manufacturing procedures; serve as a document owner.
• Assess process performance and implement solutions for process improvement.

Skills

Change Controls

GMP compliance

Root Cause Analysis

Training materials

Process validation

Documentation ownership

Quality systems

Cross-function collaboration

Education

Bachelor's degree in Life Sciences/Engineering

Tools

EBRs

CAPA tools

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 initiating, revising, approving, and maintaining manufacturing procedures, serving as the document owner and ensuring procedures accurately reflect current operations.
• Ability to assess process performance through floor observations and performance data analysis, and to identify, plan, and implement process improvement opportunities.
• Experience developing training materials and providing training on scientific and technical aspects of manufacturing processes.
• Knowledge of cGMP requirements and other applicable regulations, with the ability to ensure processes and procedures remain compliant.
• Ability to identify, assess, and mitigate process risks to ensure product safety, purity, quality, and manufacturing efficiency.
• Experience maintaining and ensuring alignment of Electronic Batch Records (EBRs) with current manufacturing processes and supporting related training activities.
• Experience supporting the development and implementation of process validation protocols and reports.
• Ability to participate in regulatory inspections and provide technical support as required.
• Experience participating in New Product Introduction (NPI) activities, including assessment of documentation, materials, training, and equipment modification requirements.
• Ability to assess, prioritize, support, and provide project management assistance for process and equipment modification projects.
• Experience owning and managing Change Controls, ensuring timely implementation within established timelines and goals.
• Ability to support Manufacturing Change Owners in the preparation and review of CCRB packages impacting manufacturing processes.
• Experience participating in non-commercial manufacturing runs to support process data collection, analysis, and evaluation.
• Ability to participate in the assessment and implementation of special projects, process improvement initiatives, and other manufacturing-related activities.
• Shift: Admin 8am-5pm | OT may be required 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.