Regulatory Documentation Manager
Irvine, CA | Work from home flexibility
Job Description
Title: Quality Document Systems Management Coordinator II
Location: Irvine, CA (Hybrid)
Note: This is a W2 contract role – C2C, 1099, & 3 rd party candidates WILL NOT be considered
The Quality Document Systems Management Coordinator will;
- Review APM Quality Assurance procedures and interact with document owners to ensure the correct documents are transferred and assigned
- Support special projects, including documentation remediation, training assignment, and records retention in collaboration with team members; identify opportunities for improvement, including developing and proposing solutions
- Maintain accurate records of APM documentation, following and improving Quality System Documents
- Ensure all documentation meets formal requirements and required standards; monitor compliance with those standards
- Produce document progress reports for senior managers
- Conduct regular reviews and document audits
- Ensure documents are delivered at key times to facilitate timely project completion
- Serve as the conduit between various departments, promoting cohesive strategies to address quality issues and mitigate risk
- Adhere to all company rules and requirements
Position Qualifications:
- 5+ years of relevant professional experience in regulatory documentation or quality control
- Ability to manage confidential information with discretion
- Strong computer skills, including working knowledge of Microsoft Office Suite programs, and strong technical writing skills
- Strong communication and interpersonal relationship building skills
- Strong attention to detail and problem-solving skills
- Ability to build stable working relationships internally, working in a team environment under general supervision and with instructions for routine work
- Bachelor's Degree in Engineering, Electrical, Mechanical, Biotechnology, or other related field
Note: This is a W2 contract role – C2C, 1099, & 3 rd party candidates WILL NOT be considered
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