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Job Description
Job Title: Quality Assurance Specialist III / Data Integrity Compliance Officer
Last Review Date: 04Jan2021
Summary
Supports the organization with compliance and ongoing preparation, testing and monitoring of conformance to established quality assurance processes and standards. Performs evaluation of internal controls, communications, risk assessments and maintenance of documentation as related to compliance with internal and external safety, quality, and regulatory standards. Identifies risk and evaluates deficiencies while working with internal departments/business units to appropriately remedy them.
Facilitates internal training on quality assurance/data integrity requirements, processes, and procedures. Supports the organization with responsibility for creating training materials, delivery of training to staff, proactively fostering a culture of Data Integrity, and resolving Data Management issues.
Essential Functions
Assures compliance with cGMP regulations, Thermo Fisher standards, and applicable regulatory requirements. Resolves Quality Assurance issues complex in scope following cGMP regulations and Thermo Fisher standards. Drives improvement of processes of the quality system. Authors, revises, reviews, and approves controlled documents in compliance with cGMP regulations. Performs assigned tasks and work to achieve company goals and department objectives. Tracks and/or manages Corrective and Preventative Action (CAPA) system. Assists in customer and/or regulatory audits. Establishes and chairs the Data Integrity Governance Team meetings. Provides assessments and status updates to aid Data Integrity Governance team's actions to maintain and proactively improve data integrity. Communicates regularly with site and above-site Data Integrity teams. Communicates actions, compliance gaps, and commitments to respective areas, including senior site management and corporate. Maintains and reports Data Integrity metrics as assigned. Ensures all new equipment and instrumentation is assessed appropriately and validated for its intended use and existence, usage, and review of audit trails and 21CFR Part 11 and Annex 11 regulations. Establishes and leads a surveillance program to audit all CGxP facilities within the site for compliance to establish documentation and data integrity standards, practices, and procedures. All other tasks as assigned for Specialist II or Specialist III duties.
Education
Bachelor's degree required in physical science, chemistry or related field.
Experience
Ideal experience includes at least 5 years of Quality Systems/Assurance experience in a regulated industry, or 5 years with related technical knowledge including data integrity related to quality control data from chromatographic systems, knowledge of laboratory instrumentation and/or operations equipment and associated computer systems.
Equivalency
Equivalent combinations of education, training, and relevant work experience may be considered.
Competencies
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