As a Quality Specialist, this specialist will play a crucial role in ensuring compliance with FDA regulations and guidelines. Specialist will be responsible for managing regulatory submissions, conducting research, and providing support for various regulatory activities.
Responsibilities:
Conduct research to stay updated on FDA regulations, guidelines, and industry best practices
Prepare and submit regulatory documents like product registrations, and annual reports
Assist in the development and implementation of quality assurance processes and procedures
Participate in project management activities related to regulatory affairs, including timelines, milestones, and deliverables
Provide guidance on compliance management activities, including labeling requirements and adverse event reporting
Support in executing CAPA, Change Control, Customer Complaints, Non-conforming Reports
Supports in external/internal audits
Ensures documents are readily available in electronic format and accessible to all employees
Ensures documents follow Good Documentation Practices
Crates and maintains documentation such as procedures, work instructions and forms.
Supports training program, onboard training, monitoring and creating metrics.
Skills:
Experience in conducting research and analyzing scientific data
Experience in quality assurance processes within a regulated industry
Understanding regulatory submissions
Excellent project management skills with the ability to prioritize tasks and meet deadlines
Strong attention to detail and accuracy in documentation
Effective communication skills to collaborate with cross-functional teams
Experience Required
Job type: Full-time
Schedule:
8 hour shift
Monday - Friday
OT as required
Pay rate: $27-$30 based on experience
Seniority level
Entry level
Employment type
Full-time
Job function
Quality Assurance
Industries
Staffing and Recruiting
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