Senior Quality Assurance Specialist
Location
Plymouth Meeting, PA
Level
Senior
Department
Operations
Type
Full - Time
Salary
Job Description
Posted on:
April 15, 2023
This role is an important member of QA Group to coordinate and maintain the SOPs, QA documents and training program, to ensure adherence to internal and regulatory requirements. The candidate will also be responsible to implement electronic quality management system (eQMS) Document Management and Training Management components.
Responsibilities
- Lead Document Management: Work with Quality team members and independently to create; handle review, approval and obsoletion of Quality documentation including policies, standard operating procedures (SOPs) and others, as per the internal and applicable regulatory environment.
- Must have comprehensive knowledge of good documentation practices and document control concepts.
- Able to interpret regulations, guidelines, policies, and procedures
- Establish and utilize eQMS in support of Document lifecycle
- Work towards improving training management
- Collaborate with document authors to develop appropriate training materials and questionnaires.
- Conduct user on-boarding and training sessions, as needed.
- Support and advice departments on document system requirements and workflows.
- Support audits, as requested.
- Assist QA with other projects and tasks, where applicable.
- Other duties as assigned.
Job Requirements
- Bachelor’s degree education.
- Minimum 2-3+ years of quality assurance experience; level based upon experience
- Have basic knowledge of quality assurance principals, and best practices.
- Highly proficient with MS Office, past eQMS experience is preferred.
- Self-starter and own tasks to completion
- Effective problem-solving skills with a demonstrated ability to identify and quickly resolve issues.
- Excellent written and verbal communication and presentation.
- Able to work successfully in a diverse team environment
