JT937 - 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 talented professional to support manufacturing operations in Puerto Rico and the USA. You will engage in on-floor activities, change control, NPI readiness, and process improvements, collaborating across functions to ensure quality and compliance.

The role involves adapting to a non-standard shift and contributing to CAPA investigations, training material development, and technical problem solving in a fast-paced manufacturing environment.

Qualifications

• Bachelor's degree in Life Sciences, Biology, Chemistry, and/or Engineering.
• On-floor manufacturing support and analyzing process performance.
• Initiating, revising, reviewing, and approving manufacturing procedures.
• Knowledge of troubleshooting and issue resolution in manufacturing.
• Participation in New Product Introduction (NPI) activities with documentation and training assessments.
• Familiarity with Change Control processes and CCRB packages.
• Experience supporting special projects, process improvements, and manufacturing initiatives.
• Non Standard 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 skills to support manufacturing operations.
• Own change controls for manufacturing process changes.
• Support investigations into major deviations and CAPA, including root cause analyses and regulatory presentations.
• Assist in generating training materials and provide training on scientific or technical processes.
• Provide on-floor troubleshooting and cross-functional collaboration for campaigns.
• Design and support tests and documentation required for process changes and new product introductions.

Skills

On-floor manufacturing support

Process performance analysis

Change control

NPI support

CCRB packages

Process improvements

Non Standard Shift

Education

Bachelor's degree in Life Sciences, Biology, Chemistry, and/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 providing on-floor manufacturing support and assessing process performance through operational observations and performance data analysis.
• Experience initiating, revising, reviewing, and approving manufacturing procedures.
• Knowledge of manufacturing process troubleshooting and issue resolution.
• Experience participating in New Product Introduction (NPI) activities, including documentation, material, and training assessments.
• Familiarity with Change Control processes and preparation or review of CCRB packages.
• Experience supporting special projects, process improvements, and manufacturing initiatives.
• Non Standard 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.