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.
Assist manufacturing change owner on CCRB packages impacting the process.
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.
Participate in the NPI process to assess requirements for documentation, materials, training, and equipment modifications.
Support establishment of process monitoring parameters and control limits.
Collect process-monitoring data and support the assessment of deviations.
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 goa. Review equipment/system Root Cause Analysis investigations and support trend evaluations.
Qualifications: Bachelor Degree in Science or Engineering Five (5) years of Previous experience in Manufacturing Operations Experience in deviations or non- conformances Trackwise system or VIVA Change Control Shift: 8:00am to 5:00pm 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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