Quality Auditor

Quality Auditor
Company:

Software Guidance & Assistance


Quality Auditor

Details of the offer

Location: Austin, TX
Bill : $44.26 HR
Essential Job Functions:
Provides operational support the WuXi Clinical North America QA Department.
Ensure policies and procedures are monitored and updated to include regulatory changes.
Assist with development, implementation, and maintenance of Standard Operating Procedures (SOP) and Work Instructions (WI) for the Austin facility.
Help implement and evaluate QA standards that comply with GCP, ICH and industry regulations.
Aid in the development of quality procedures for documenting audits and other quality assurance activities
Assist with investigations of non-conformance issues, identify areas for improvement in the quality system, and assist with compliance outcomes with corrective and preventive actions.
Supports the preparation of reports to communicate outcomes of quality activities.
Identify training needs and organize training interventions to meet quality standards.
Performs internal process and training record audits as scheduled.
Supports the coordination of on-site audits conducted by external providers.
Must be able to work with minimal supervision.
Perform other work-related duties as assigned and required.

Experience / Education:
Bachelor's degree required, preferably in a life sciences discipline, nursing or related field.
A minimum of 3 years of experience in clinical research, pharmaceutical or CRO industry required
A minimum of 2 years of quality assurance GCP auditing experience in the pharmaceutical or CRO industry required
Advanced knowledge of FDA guidelines, Good Clinical Practices (GCP), ICH, and other applicable regulations is required.
Experience with performing vendor and system audits preferred

Knowledge / Skills / Abilities:
Must show ability to present solutions to issues using good judgment; must show ability to apply previous lessons to future project work
Must make effective decisions on managing tasks within time constraints so that deadlines are not missed
Is expected to seek direction for regulatory issues or issues that require significant changes to standards
Is able to foster teamwork inside and outside the department
Requires excellent oral and written communication skills to interact with other team members, partners, and sponsors
Must be able to build rapport and effectively communicate issues and potential resolutions to team and supervisor
Must show excellent interpersonal communication skills with a focus on customer service
Must exhibit positive, professional demeanor in all communications with other employees, management, sponsors and other outside personnel
Must exhibit concise technical writing skills in English with minimal grammatical or logical errors
Must have high level of attention to detail and ability to plan and organize
Must be knowledgeable in data collection, management, and analysis and in related problem solving
Solid knowledge of computers, Microsoft Office products, and databases

Physical Requirements:
Must be able to work in an office environment, which has minimal noise conditions
Ability to stand or sit for most of the work day
Must be able to perform some activities with repetitive motion, such as keyboarding

Requirements

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