JT922 - SPECIALIST MANUFACTURING

Quality Consulting Group, LLC; Juncos (PR); On-site; USD 80,000 - 120,000; Full time

Job summary

Quality Consulting Group, LLC is a leading provider in pharmaceutical, biotech, medical devices, and manufacturing sectors, seeking a highly motivated team member in Puerto Rico and the USA. The role covers supporting manufacturing quality systems, change controls, CAPA investigations, and risk assessments, with emphasis on document editing and process ownership.

Collaborative work with cross-functional teams is expected, ensuring compliance and continuous improvement.

Qualifications

• Experience with CAPA management, Change Controls (CC), Risk Assessments, and CDOC document editing.

Responsibilities

• Support execution of quality systems and CAPA processes.
• Own change controls for manufacturing process changes.
• Assist in risk assessments and investigations across lifecycle stages.
• Prepare, review, and revise procedures and batch records as needed.
• Provide training materials and support on technical processes.

Skills

CAPA management

Change Controls

Risk Assessments

CDOC editing

Education

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

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 in CAPA management, Change Controls (CC), Risk Assessments, and CDOC document editing.
• 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.