Quality & Regulatory Careers at MethodSense
MethodSense is a quality and regulatory consulting firm that works exclusively in the Life Sciences, guiding medical device, biotech and pharmaceutical companies as they deliver breakthroughs. We often look for qualified people who are experienced with conducting audits, overseeing business and product technology validation, as well as documenting critical business operations.
MethodSense provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws.
Quality Assurance Associate
We are seeking a Quality Assurance Associate to work closely with the MethodSense Executive Team and Project Managers to assist with the maintenance of client’s Quality Management Systems, supporting client Regulatory solutions, and the implementation and maintenance of client technology solutions on a contract basis.
» QMS Management
» Validation Project
Learn More About The Position »
Position Responsibilities and Functions:
- Assist or lead in the maintenance of Quality Management System (QMS)
- Facilitate QMS record generation and maintenance by working cross functionally to gather and document information
- Contribute to the authoring of QMS SOPs, validation documentation, service report of findings or other documentation
- Contribute to the role of document manager
- Assist with the execution of validation projects
- Support audits as needed
- Other duties as assigned by management
Skills, Knowledge and Experience:
- BS degree
- 1-3 years experience in Quality Assurance
- Excellent verbal and written communication skills
- Ability to work collaboratively in a cross functional team environment
- Basic understanding of FDA regulations 21 CFR Part 820, 21 CFR Part 11
- Software or Process validation experience
This is a contract position and the individual needs to be open to travel nationwide as well as internationally.