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 in 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.

　　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.

　　Responsible for managing NC/CAPA closure within established goal.

　　Assist with generation of process validation protocols and reports.

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

　　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.

　　Qualifications:

　　Bachelor's degree in a related field

　　Five (5) years of Manufacturing Operations experience

　　Experience managing change control, CAPA, CAPA EV on Trackwise and experience on CDOCS

　　Skilled in performance of GMP production operations.

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

　　Detailed technical understanding of bioprocessing unit operations.

　　Shift: 8am-5pm, 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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