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Quality Assurance Compliance Manager

Rosenberg, TX
Employbridge Search Group has a client in Rosenberg, TX that is looking for a Quality Assurance Compliance Manager to join their team! This is a company with competitive salary, great benefits and opportunity for growth!

Job Duties:
  • Manages, investigates and corrective action/preventative action (CAPA) quality elements; laboratory Out of Specification (OOS) and operations investigations
  • Investigates, authors, resolves non-conformance and OOS deviations in a timely manner
  • Collates information, writes justifications and manages the Continuous Quality Improvements program
  • Acts as technical resource within the plant for problem solving; Non-Conformances, OOS deviations, and CAPAs
  • Leads, performs and analyzes the tracking and trending of Quality Events, Non-Conformances, OOS investigations and CAPA(s)
  • Manages the site Quality Event escalation program associated with lot of system disposition issues and Hold Events
  • Manages the day to day activities for the timely initiation, tracking and closure of Non-Conformances, OOS(s) and CAPA(s)
  • Performs statistical and Root Cause Analysis of Quality Events data as required
  • Assists manufacturing and laboratory departments in identifying root cause and implementing effective corrective actions for circumstances where quality standards are not met
  • Trains personnel on the Investigations and CAPA system
  • Authors and reviews compliant investigations as requested within timeliness
  • Serves as back-up to Batch Records Auditor including, but not limited to, identifying all lot non-conformances
  • Provides management periodic updates on investigations and CAPA(s)
  • Perform other related duties as assigned
  • Bachelor’s Degree, preferably in Science, Engineering, Math or Statistics
  • 10+ years’ of non-conformance or investigations related experience or equivalent combination of education and experience
  • 10+ years’ of experience in GLP or GMP environment
  • Able to interpret GMPs and other government regulations
  • Able to coach and train personnel on the investigations and CAPA system
  • Knowledge of manufacturing/processing techniques, laboratory procedures, Root Cause Analysis and statistical applications is preferred
  • Must have strong written and verbal communication skills
  • ASQ, Black Belt or Green Belt certifications is a plus
  • Must demonstrate initiative, innovation and sound analytical problem-solving skills
  • Able to build rapport with coworkers and partner with other departments

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