Production Specialist 1
Current-Manufactured and assembled various products with specialization in Gel Beads-Followed GDP, transacted materials in multiple ERP systems, ensured data traceability-Provided significant assistance to R&D during initial development phases-Drafted Work Instruction and Production Batch Record documents for new processes and continual process improvement initiatives-Worked with cross-functional teams to edit protocols and procedures with input from a variety of stakeholders-Supported numerous project transfers from process development to manufacturing-Gave input on various scale-up operations-Took part in failure investigations and subsequent corrective actions-Formally documented nonconformances and deviations in ISO 9001 compliant quality system-Performed build and yield tracking and helped in data trending of key performance indicators, analyzed and suggested actions based upon results-Assisted in production planning based upon personnel and equipment capacity limitations-Aided the company in growing from a ~20-person team into a company with headcount in the hundreds-Worked with, troubleshot, and maintained multiple pieces of custom manufacturing equipment (Implementation and IQ/OQ/PQ work included in this)-Trained coworkers in numerous processes