About the role
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: * 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