JT716 - SPECIALIST MANUFACTURING

Quality Consulting Group, LLC; Juncos (PR); On-site; USD 70,000 - 90,000; Full time

Job summary

Quality Consulting Group, LLC is seeking a motivated professional to join our team in Puerto Rico & USA. The role focuses on supporting manufacturing systems, change controls, and process improvements within a world-class manufacturing environment.

Ideal candidates hold a Life Sciences/Engineering degree and have hands-on manufacturing operations experience. Responsibilities include document management, training, and on-floor troubleshooting to ensure compliance and efficient production

Qualifications

• Bachelor's degree in Life Sciences, Biology, Chemistry, and/or Engineering.
• Manufacturing Operation experience (not quality).
• Document management: create, review and approve documents.

Responsibilities

• Support manufacturing/quality systems including non-conformances, process validation, procedures, training and new product introductions.
• Own change controls for manufacturing process changes and assist with CAPA investigations.
• Assist in generation of training materials and provide training on scientific/technical aspects of the process.
• Provide on-floor troubleshooting and assist with process performance assessments.

Skills

Manufacturing operations

Document management

Administrative shift

Education

Bachelor's degree in Life Sciences/Biology/Chemistry/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.
• Manufacturing Operation experience(not quality)
• Document Management, create new documents, review and approval of documents.
• 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.