Coord, Document Control

West Pharmaceutical Services / Progressive Medical; Kinston (NC); In loco; USD 50.000 - 75.000; Tempo pieno

Descrizione del lavoro

RXinsider LTD. in Kinston seeks a document control and learning management professional to support a multi-functional Quality team.

You will manage document control and database administration activities, ensuring compliance with internal procedures and regulatory requirements. Key duties include coordinating the Kinston site’s document control program, publishing controlled documents, creating lab notebooks, and ensuring reviews occur within a three-year interval.

Competenze

• High school diploma or equivalent.
• Experience with document control in a regulated industry is a plus.
• Excellent written and verbal communication skills.
• Ability to work independently in a fast-paced environment.

Mansioni

• Coordinate the Kinston site's document control program and route documents for approval.
• Publish and maintain controlled copies of documents.
• Create laboratory notebooks and logbooks.
• Ensure procedures are reviewed within a 3-year interval.
• Review corporate procedures and implement local changes.
• Assist QA Management in day-to-day operations.
• Perform internal audits to verify adherence to procedures.
• Recommend and implement process improvements to the quality management system.
• Comply with all regulations, policies, safety rules, and company SOPs.
• Exhibit regular, reliable attendance and support other duties as needed.

Conoscenze

Leadership

Organization

Independent work

Communication

Problem solving

Interpersonal skills

Windows OS

Microsoft Office

Data organization

Formazione

High school diploma or equivalent

Strumenti

Windows OS

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Document management system

Descrizione del lavoro

Job Summary

This role is accountable for providing document control and learning management services to support a multi-functional team environment. This role will support document control and database administration activities within the Quality team and will identify areas of improvement. This role will handle projects and tasks consistent with internal procedures and acceptance criteria, while meeting company and regulatory requirements.

Essential Duties And Responsibilities

• Coordinate the Kinston site's document control program. Route procedures, protocols and other documents for approval.
• Publish and maintain controlled copies of documents.
• Create laboratory notebooks and logbooks.
• Ensure that all procedures, work instructions and forms are reviewed within a 3 year interval.
• Review new and revised corporate procedures, ensuring any lower-level document changes are implemented into Kinston procedures where applicable.
• Assist QA Management in day-to-day operations.
• Perform internal audits to assess the adherence of the plant to approved and established procedures and requirements.
• Recommend, evaluate, and implement process changes that are designed to continually improve the quality management system.
• Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.
• Performs other duties as assigned based on business/departmental needs.
• Exhibits regular, reliable, punctual and predictable attendance.

Preferred Knowledge, Skills And Abilities

• Good leadership and organizational skills are required.
• Quality experience preferred.
• Ability to work independently, multi-task and thrive in fast-paced environment.
• Excellent written and verbal communication skills.
• Must have effective problem solving and interpersonal skills.
• Proficient in Windows OS, Microsoft Office Suite including Word, Excel, and Power Point.
• Experience with managing Document Control activities within a regulated industry a plus.
• Experience with quality systems preferred.
• Experience with Master Control or electronic document management systems a plus.
• Ability to accurately collect and organize data.
• Able to be aware of all relevant SOPs as per Company policy and Quality Manual.
• Able to comply with the company’s safety policy at all times.

Education

• High school or equivalent.

Travel Requirements

5%: Up to 13 business days per year

Physical Requirements

Sedentary-Exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time.

Shift

In-office Monday -Friday 8.00am -5.00pm