Quality Systems Specialist II – Data Integrity
4 months ago
Essential Duties and Responsibilities
: Responsible for maintaining data governance program, including design (i.e., establishment of data process flows, assignment of risk rankings, identification of required controls), operation support (e.g., business process/GXP computerized system data integrity issue investigation), and monitoring. Provide mentorship and advice on approved procedures, standardization and requirements associated with the quality management system (QMS) and data integrity, including ALCOA+. Lead data integrity investigations and work cross functionally to determine root cause and CAPAs. Support audit trail reviews. Analyze metrics to measure the effectiveness of the data governance program. Subject Matter Expert and Key User supporting data integrity and good documentation practices (GDocP). 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). Support 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. Perform other duties as required.Basic Qualifications and Capabilities:
Bachelors 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) Works on multiple assignments in collaboration with various department system owners. Excellent interpersonal, verbal and written (including editing) communication skills are crucial in this collaborative work environment. 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. Proactively identify and work collaboratively to resolve problems by taking risk-based and compliant approaches to solutions.-
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