JT686 - SPECIALIST MANUFACTURING

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

Job summary

Quality Consulting Group, LLC is seeking a highly motivated teammate to join our manufacturing quality team in Puerto Rico and the USA. You will support quality systems, manage change controls, and contribute to process validation, investigations, and CAPA activities.

Responsibilities include developing training materials, participating in risk assessments, and aiding in campaigns with cross-functional teams.

Qualifications

• : Bachelor’s degree in Life Sciences, Biology, Chemistry, and/or Engineering.
• : Knowledge of document management within Veeva Vault (CDOCs) or similar platforms.
• : Strong technical writing skills.
• : Experience handling change controls as the owner.
• : Proven project management experience.
• : Proficiency in Smartsheet or similar project management platforms.

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 including Root Cause Analysis, CAPA actions, and regulatory inspection readiness.
• Assist in risk assessments and microbial assessment evaluations.
• Lead campaign readiness and collaborate with cross-functional areas.
• Generate training materials and provide training on process-related topics.
• Provide on-floor troubleshooting and commercial support when needed.
• Design, coordinate, and support functional/ water tests and other runs during major changes.

Skills

Documentation writing

Project management

SMartsheet

Quality systems

Education

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

Tools

Veeva Vault/CDOCs

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.
• Knowledge of document management within Veeva Vault (CDOCs) or similar platforms.
• Strong technical writing skills.
• Experience handling change controls as the owner.
• Proven project management experience.
• Proficiency in Smartsheet or similar project management platforms.
• Administrative Shift

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.