Job Description

Quality Control Analyst II

This role, under supervision of QC EM System management, will function as an Environmental Monitoring (EM) database application administrator. The responsibilities of this role include: Supporting & maintaining the integrity of EM database applications (MASTER and PharmNet-Web) by creating/maintaining sites, templates, and alarm levels. Implementing changes to database applications per documented procedures and facilitating training for systems to all applicable employees. Supporting corrections using controlled quality forms (Data Management System Requests). Identifying errors as part of the monthly status review, communicating errors and drive corrections to completion, or escalate when deviations are required. Assuring EM Program, Area-specific SWI and MASTER Templates and PharmNet-Web sites and alarms are in alignment; report errors to management where required. Programming and managing airborne particle monitoring equipment (Lasairs) for use in conjunction with the EM database applications. This position may also be required to perform testing in the database applications to support bug fixes and version updates. This position will be required to perform special projects as assigned.

Basic Qualifications:

• Experience in use and/or administration of an EM database application
• Familiarity of cGMPs in a pharmaceutical environment
• Familiar with 21CFR part 11 data integrity best practices in pharmaceutical environment
• Excellent written and verbal communications skills and the ability to lead and participate in teams
• Experience or familiarity of Manufacturing and/or Laboratory Environments, especially environmental monitoring processes

Preferred Qualifications:

• Experience in database application/system master data management, testing, and validation lifecycle activities
• Experience in development and delivery of end user training, especially in using Storyline or Captivate

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