A Quality Assurance Specialist III job in Richmond, VA is available through Modis Engineering. The Quality Assurance Specialist III. In this role, you will be responsible for identifying, leading, and/or supporting quality, regulatory, and compliance improvement initiatives, projects, and remediation activities that support Toxicology business entity activities. This position will focus on implementing and maintaining effective document control and training compliance, building and maintaining alignment of quality and operational processes to corporate and division policies and applicable regulations, and deploying these Quality System processes to one or more entities. This is a 6+ month long contract opportunity. The salary for this position is between $25.00 and $28.00 per hour.
Quality Assurance Specialist III job responsibilities include:
• This role supports the development, implementation, improvement, and/or effectiveness of Quality Systems in compliance with applicable ISO, FDA, and other regulatory agency regulations and standards through implementation of effective Quality System programs.
- Uses skills to establish and manage an effective document and change control process for the assigned business entity, and may include the deployment of shared processes across various Toxicology entities.
- Supports multiple quality system areas such as Document Control, Management Review, Quality Metrics, and training administration while sharing knowledge through best practices and risk mitigation strategies.
- Manages assigned data collection, performance metrics, evaluation, analysis and scientific writing of reports results to site and/or Business Unit leadership. Provides, and may execute, suggested remediation activities.
- Works directly with entities in establishing compliant Quality System processes and programs.
- Leads or assists internal and external audits as assigned.
- Understands and is aware of the quality consequences which may occur from the improper performance of their specific job; has awareness of the impact of testing best practices on testing outcomes and confidence in testing veracity.
- Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices; build productive internal/external working relationships
• Bachelor’s degree or related equivalent experience
- Minimum of 5 years of experience in Quality Assurance activities in a medical device or pharmaceutical industries, or within a related industry or role with exposure to quality practices and quality processes.
- Industry experience in managing document control processes and software.
- Experience managing or supporting a quality system training program.
- Thorough knowledge and practical application of Quality System Regulations or other applicable regulatory area or standard scheme.
- Ability to articulate complex quality and regulatory matters with persons of a variety of backgrounds.
• Strong analytical, written, people-influencing and verbal communication skills.
- Effective organizational and time management skills.
- Must show strong self-initiative and be comfortable in the role of a team player.
- Must be able to work independently with minimal supervision.
- Prior experience with FDA or related audits.
- Experience with service level quality or software quality is preferred.
- ASQ Certification or equivalent is beneficial.
- Must have capability to review, analyze, summarize and interpret quality systems data, draw conclusions, make appropriate decisions and recommendations, write reports and best practices and give oral presentations.
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Equal Opportunity Employer/Veterans/Disabled
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The Company will consider qualified applicants with arrest and conviction records.