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Quality Assurance Specialist II
2 months ago
About the Role
Civica is seeking a highly skilled Data Integrity Specialist II to join our team. As a key member of our quality assurance team, you will be responsible for maintaining our data governance program, including design, operation support, and monitoring.
Key Responsibilities
- Design and implement data process flows, assign risk rankings, and identify required controls to ensure data integrity.
- Investigate data integrity issues and work cross-functionally to determine root cause and implement corrective actions.
- Provide mentorship and advice on approved procedures, standardization, and requirements associated with our quality management system (QMS) and data integrity.
- Support audit trail reviews and analyze metrics to measure the effectiveness of our data governance program.
- Develop and deliver training to new staff on data integrity and other processes and procedures.
- Support audits and inspections, and promote a culture of quality and data integrity compliance.
- Execute critical initiatives to improve our 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, and management review.
- Proven experience leading and writing investigations, and ability to lead risk assessments and root cause analysis.
- Experience with cGMPs and quality system regulatory requirements, as well as quality computerized system applications.
- Excellent interpersonal, verbal, and written communication skills, with ability to work independently and collaboratively with scientific/technical personnel.
- Strong organization and execution skills, with attention to detail and ability to adjust workload based on changing priorities.
About Civica
Civica is a leading provider of software and services to the public sector. We are committed to delivering high-quality solutions that meet the needs of our customers.
