ACL Digital

QA Documentation Specialist - II

San Mateo, CA, US

Onsite
Full-time
about 2 months ago
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Summary

JOB RESPONSIBILITIES: QA Trainer Support compliance with the IT Training Administration Program by supporting IT Staff with the assignment of GxP training, creation and maintenance of training curricula, review of document training assignments, creation and maintenance of training records, and assisting IT staff with general training queries. General Job Responsibilities Include: Monitors department mailbox, addresses and resolves customer questions promptly, maintains close cooperation and communication with globally dispersed personnel Enters training completion data and training records into the Training System Provides quality oversight through review and analysis of records/data for compliance and consistency with procedural and regulatory standards. Performs quality control of entered data and follows appropriate procedures to ensure the quality of information contained in the Training System May assist in training plan and/or curricula development Provides ongoing user support/training on system(s) and department processes Supports the periodic review of training courses and training curricula. Supports the maintenance of metrics and reporting related to quality systems. May under supervision of a more senior professional assist with system/process improvement initiatives. May provide operational support during audits and regulatory agency inspections. KNOWLEDGE & SKILLS: Good oral and written communication skills, as well as effective interpersonal skills, is able to work efficiently with customers and colleagues across geographical locations Customer oriented but understand the compliance-driven nature of the position Proficient with Microsoft Word and Excel (advanced skills preferred) Possess good organizational and time management skills Comfortable learning new computer applications Systematic in obtaining and using information Good attention to detail and ability to consistently meet high standards of quality required in compliance Able and willing to execute repetitive tasks with a consistent level of high quality and productivity Able to work under tight deadlines while delivering a high-quality output Able to operate both as an individual contributor and as a dependable, collaborative team member Able to work independently, but able to identify problems and know when to solve proactively and when to seek advice Demonstrate willingness to learn and become a proficient team member BEHAVIOURS: Resilient profile with the ability to deliver in an ambiguous environment Ability to engage and manage multiple stakeholders to achieve the objective Curious with learning agility Operationally excellent Organised with systematic approach to prioritisation Process orientated to achieve the business objective EDUCATION & EXPERIENCE: 3+ years of relevant experience in a regulated industry. Experience working in the Pharmaceutical industry is desirable. Familiarity with/use of validated document management and learning management system software, and applications e.g. Veeva Vault, UL Compliance Wire is desirable

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