Job description  –  Quality Specialist II

Support and maintenance of the quality system to include document control and facilitation of systems. To ensure a culture of compliance throughout the facility and performs all responsibilities in accordance with company policies, procedures, and federal regulations.
 

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Responsible for day-to-day management of quality records.
  • Provides daily CAPA management for site metrics
  • Updates the Quality Performance Boards daily
  • Maintains the CAPA spreadsheet
  • Maintains CAPA files from creation to completion to ensure CAPAs closures are in compliance and follow GDP
  • Works across boundaries to ensure timely completion of CAPA records
  • Provides Quality oversight and coaches various department owners on CAPA methodology
  • Creates and conducts training on the CAPA process for Cognate Site.
  • Works with the Quality Systems team to ensure all quality systems are aligned
  • Maintains the CAPA program SOPs
  • Reviews and approves Corrective and Preventative Actions (CAPA); includes tracking, follow-up, and reporting/trending and evaluating CAPA for effectiveness.
  • Assist with daily activities related to processing and maintenance of controlled GMP documents associated with document management functions (procedure, specifications, reports and batch records).
  • Participates in continuous improvements to applicable Standard Operating Procedures (SOPs). Electronic systems related to document control, quality systems and other duties as assigned.
  • All additional duties assigned by Quality Systems Manager

 

EDUCATION AND/OR WORK EXPERIENCE REQUIREMENTS:

  • Minimum of 4 years GMP related experience in biopharmaceutical/pharmaceutical or related industry.
  • Experience with GMP regulatory requirements.
  • BS/BA Life Sciences or related field
  • Excellent 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.

 

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