Job Description
Our Biopharmaceutical Client is seeking a Quality Compliance Specialist for Bioanalytical Data and Lab Systems to ensure compliance with policies, quality standards, workflow procedures, and regulatory and accreditation requirements. This position will be responsible for conducting quality compliance audits of scientist and engineer records and lay systems, maintaining detailed auditing records, preparing trending reports, and monitoring auditing results to support optimal data integrity and continuous innovation and compliance. This individual will record the scientist and engineer audits to ensure completeness and accuracy, including comparing source data to the records for accuracy and analyzing select data in detail. They will audit department records and processes related to the bioanalytical data and lab systems. This could include feedback surveys, after action reviews, and lab documentation. They will prepare records for audits performed by staff such as supervisor reviews, project reviews, and internal audits, and identify opportunities for improving the quality and efficiency of records and processes. The Compliance Specialist will utilize tools, systems, and methods, to organize and catalog various auditing data and perform data and statistical analysis on auditing data to generate metrics and other tracking and trending analytics.
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Skills and Requirements
Bachelor's Degree in a science-based, quality, or engineering discipline
? Strong knowledge and hands-on experience working with quality management systems, standards, and regulations relevant to the industry, such as Good Laboratory Practices (GLP) or Good Manufacturing Practices (GMP).
? Proficiency in performing laboratory inspections, audits, investigations, root cause analyses, and corrective actions.
-? Experience working with testing procedures, quality metrics, and statistical analysis.
-? Familiarity with document control, change control, and risk management processes.
-? Experience collaborating with cross-functional teams to ensure compliance and continuous improvement.
