Document Control Manager

No More Needles

Fremont, California

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JOB DETAILS

SKILLS

Code of Federal Regulations, Communication Skills, Computer Skills, Detail Oriented, Develop Methodologies, Document Control, Document Management, Documentation, External Audit, FDA (Food and Drug Administration), ISO (International Organization for Standardization), Industry Standards, Interpersonal Skills, Medical Equipment, Multitasking, Onboarding, Organizational Skills, People Management, Problem Solving Skills, Process Development, Product Data Management (PDM), Product Lifecycle Management, Quality Engineering, Quality Metrics, Quality System Requirements (QSR), Regulations, Regulatory Requirements, SolidWorks, Staff Training, System Validation, Team Player, Time Management, Training/Teaching, Trend Analysis, Vendor/Supplier Management, eCos

LOCATION

Fremont, California

POSTED

9 days ago

GENERALINFORMATION

Position Title	Document Control Manager
Department	Quality
Reports To	VP, Quality Assurance

Purpose of the job

The Document Control Manager is responsible for managing all document control activities for Rani Therapeutics. This includes the development, administration, maintenance and monitoring of the company's document control activities in accordance with FDA/QSR/QMSR, ISO 13485 requirements and applicable international regulations. In addition, this position is responsible for administration and maintenance of a robust company-wide training system, providing personnel training, preparing for external audits/visits, procedure/form updates and supporting streamlining the QMS.

Major Duties and Responsibilities

Administer all aspects of the Arena PLM/QMS system for Rani Therapeutics
Identify opportunities to improve PLM/QMS controls; collaborate with Arena representative to discuss and implement changes
Interface with Rani Quality Engineering to document the assessment and/or Part 11 validation of system changes prior to implementation
Develop, manage, and maintain document control and training processes and procedures in conformance to industry standards/requirements
Co-develop Training Plans with functional management; implement and maintain company-wide QMS training system
Coordinate review of ECOs for accuracy and completeness prior to routing; work with initiators to minimize rejections and withdrawals
Coordinate on-boarding and routine training to Arena users
Create and present trend analysis (e.g., ECO and Training Quality Metrics) on a routine basis
Procure, organize and maintain a library of external documents (e.g., Standards) that are used in support of company activities/products
Provide guidance and recommendations for adherence to Rani Therapeutics procedures based on regulatory requirements
Prepare documentation and provide training for initiators of ECOs
Evaluate and develop improved techniques and use of tools for the control of documents and quality records
Provide backup support for supplier files and supplier approval list in accordance with the Supplier Management procedure
Other duties/ activities may be necessary to support departmental or company goals

Experience & Education

5 years’ experience at a Document Control manager level in the Medical Device industry
10 years’ experience in regulated industry with demonstrated quality system knowledge including 21 CFR Part 11, QMSR/21 CFR Part 820 (QSR) & ISO 13485
Experience developing documentation processes and procedures
Individuals must have a hands-on approach
Ability to work on multiple projects simultaneously
Experience with related PDM systems desired (e.g. SolidWorks)
College degree desired

Skills and Specifications

Ability to motivate and influence people
Organizing, planning, and problem-solving skills
Strong organizational and time management skills with high attention to detail
Good interpersonal and communication skills
Excellent computer skills
Ability to work as a part of a team
Ability to create and provide training

About the Company

No More Needles

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