As the world's largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. We supply prestigious life sciences and biopharma companies with job seekers like you to achieve their business goals. If you're looking for a position where you can serve as an asset to your company while making a difference in others' lives, we have the ideal position for you!
This role requires employees to be fully vaccinated against COVID-19 as a condition of employment.
location: North Billerica, Massachusetts
job type: Permanent
salary: $52,000 - 78,000 per year
work hours: 9 to 5
The Quality Management System Technical Specialist supports the company's Quality Systems processes, both paper and within the electronic Quality Management System. This individual supports the maintenance and enhancement of existing processes (change control, quality events, controlled documentation, records management, training, and others) and the implementation of new systems and processes.
- Support the electronic Quality Management System (CATSWeb QMS) and its users as a business-level superuser / administrator. Train users / develop training material, help users find information in the system, trouble-shoot process issues, and participate in implementation of updates and enhancements to Quality Systems processes; including change control, CAPA, deviations, complaints, document management, and training.
- Propose and implement improvements to Quality Systems business processes, to increase efficiency, enhance compliance and reduce system maintenance requirements.
- Provide project and validation support for all activities involving modifications, upgrades and or business process changes related to Quality Systems applications. Author validation documentation and execute validation activities in accordance with company and industry standards.
- Participate in the design and implementation of new or updated processes. Collaborate with end users to document user and functional requirements for new implementations or upgrades to processes and systems. May act as a business lead for small to medium size projects.
- Partner with the IT organization and vendors to resolve issues and manage initiatives related to the Quality Management System.
- Work as a team player across many functions, departments, and groups, acting as a technical / quality management system resource.
- Support regulatory agency inspections as a Subject Matter Expert and by participating in back room processes, such as information retrieval.
- Actively promotes safety rules and awareness. Demonstrates good safety practices at all times including the appropriate use of protective equipment. Reports and takes initiative to correct safety & environmental hazards.
- Actively demonstrates the company values.
- BS/BA degree in a scientific or technical field, with a minimum of 5 years experience in a GxP environment.
- Experience with electronic Quality Management Systems at the technical support level is highly desirable. Experience with the support of CATSWeb QMS is a plus.
- A combination of education, training and experience may be considered in lieu of the above stated qualifications.
- Must have excellent written, verbal, and presentation skills. Must be able to interact effectively with all levels of management.
- Excellent organizational, analytical, and problem-solving skills and strong attention to detail.
skills: Quality Assurance, CAPA
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.