Data Integrity Specialist II

3 weeks ago

Petersburg, United States Civica Full time
Job Summary

We are seeking a highly skilled Quality Systems Specialist II – Data Integrity to join our team at Civica. This role will be responsible for maintaining our data governance program, providing mentorship and advice on quality management systems, and leading data integrity investigations.

Key Responsibilities
  • Maintain data governance program, including design, operation support, and monitoring.
  • Provide mentorship and advice on quality management systems and data integrity.
  • Lead data integrity investigations and work cross-functionally to determine root cause and CAPAs.
  • Support audit trail reviews and analyze metrics to measure the effectiveness of the data governance program.
  • Subject Matter Expert and Key User supporting data integrity and good documentation practices.
  • Identify and raise data integrity compliance gaps across the quality system.
  • Develop and deliver training to new staff on data integrity and other processes and procedures.
  • Support audits (internal, regulatory) and inspection readiness activities.
  • Promote a culture of quality and drive enthusiasm for data integrity compliance.
  • Execute critical initiatives to improve the quality system and data integrity.
Requirements
  • Bachelor's degree with 6+ years of combined technical experience in a GMP-related field within a pharmaceutical/biologics manufacturing facility.
  • Experience with quality systems and demonstrated working knowledge in areas such as data integrity, change control, deviation, CAPA, Management Review.
  • Demonstrated experience leading and writing investigations.
  • Ability to lead risk assessments and root cause analysis.
  • Experience with cGMPs and Quality System regulatory requirements.
  • Experience with quality computerized system applications (e.g., Veeva).
  • Excellent interpersonal, verbal, and written (including editing) communication skills.
  • Ability to communicate and work independently with scientific/technical personnel.
  • Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities.
  • Strong organization and execution skills with an attention to detail.
  • Committed to delivering high-quality results, working with others to overcome challenges, and focusing on what matters.
  • Continuously looking for opportunities to learn, build skills, and share knowledge with others.

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