JT600 - SPECIALIST MANUFACTURING

QUALITY CONSULTING GROUP, a leader in the 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 : Initiate, revise, and approve manufacturing procedures.

Ensure all procedures reflect current operations.

Serve as a document owner.

Assess process performance by observation of floor operations and review of performance data.

Evaluate, plan, and implement solutions for process improvement opportunities.

Provide troubleshooting support.

Assist in generation of training materials and may assist in providing training on scientific or technical aspects of the process.

Support establishment of process monitoring parameters and control limits.

Collect process-monitoring data and support the assessment of deviations.

Provide support of timely execution of the process monitoring quarterly reports, Non-Conformance and CAPA.

Ensure that all Non-conformances are triaged within the established goal.

Responsible for authoring investigation reports.

Responsible for execution of corrective actions.

Responsible for managing NC / CAPA closure within established goal.

Monitor and communicate incidents trends.

Review equipment / system Root Cause Analysis investigations and support trend evaluations.

Assist with generation of process validation protocols and reports.

Assist with the execution of the process validation.

Support collection and analysis of process validation data.

Participate in the NPI process to assess requirements for documentation, materials, training, and equipment modifications.

Assess, prioritize, justify, and provide implementation and project management support for process or equipment modification projects.

Assist manufacturing change owner on CCRB packages impacting the process.

Participate on the assessment or implementation of special projects or initiatives.

Qualifications : Bachelor's degree in related area 5 years of Manufacturing Operations experience  Detailed technical understanding of bioprocessing unit operations.

Skilled in performance of GMP production operations.

Regulatory knowledge and interactions.

Ability to communicate and collaborate with technical and management staff within manufacturing, process development, and quality.

Experience writing SOP Experience in equipment / process Experience in creating new SOPs and provide training to manufacturing personnel.

Basic project management skills.

Basic knowledge of control charting.

Shift : Non-Standard shift (8hrs shift, OT 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.

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