Job description  – Quality Support Specialist

Employee will learn the QA departments’ objectives, procedures, & functions while contributing to daily department operations. Employee will be responsible for gowning daily and monitoring processes performed in the clean room and suites, until the process is complete. The employee will also be responsible for ensuring all processes are performed in a manner that meets all Cognate mandated GMP standards and all documentation is recorded based on Cognate mandated GDP standards.
 

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Responsible for day-to-day BPR Corrections
  • Performs line clearance and provides manufacturing support
  • Daily Log Review
  • Catch real-time deviations, if any occur
  • Perform Equipment Calibration Checks
  • Perform Material Checks (Expiration Dates)
  • Perform in-process visual checks to ensure consistency and GMP
  • Review in-process batch documentation, to ensure real-time compliance to GDP
  • Provide guidance to operators, verifiers, and other MFG staff
  • Must be able to stand for long periods of time
  • Must have great problem solving skills, as well as pay high attention to details
  • Must provide guidance with aseptic technique and good practices

 

EDUCATION AND/OR WORK EXPERIENCE REQUIREMENTS:

  • Minimum of 1 year GMP related experience in biopharmaceutical/pharmaceutical or related industry.
  • Experience with GMP and GDP regulatory requirements.
  • BS/BA Life Sciences or related field
  • Excellent organizational, written, and verbal communication skills.
  • Ability to prioritize daily activities in order to meet client needs on time of established timelines in a fast-paced environment.
  • Ability to monitor and report on assigned tasks, goals, and objectives.
  • Well versed in Aseptic Technique and Clean Room Behaviors

 

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