Regulatory Documentation Manager

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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