Position Summary

This is a temporary position for 3 months. Monday through Friday 7am-4pm.

The Comapny's Document Control Team is a key element of the Quality Assurance department and is responsible for the control, management and storage of all company quality records. As a member of the Document Control Team, and under the direction of department management, this position provides support and guidance to Inova departments by processing a variety of Electronic Change Orders (ECOs) of varying complexity submitted through the company’s Enterprise Resource Planning (ERP) system, SAP. Responsible for identifying and resolving ECO-related issues, in compliance with documented procedures. Works closely with department management and team members to ensure the Document Management System within SAP is maintained and in compliance with established procedures. Completes all work in accordance with Inova Quality Management System.

Responsibilities

Key Accountabilities

Provides the first point of contact for ECO initiators regarding ECO initiation process.
Processes a variety of ECOs of varying complexity.
Manages workload by working with initiators, and others as needed, to ensure ECOs are completed accurately, in compliance with documented procedures and in a timely manner.
Analyzes and interprets the intention of the proposed change and its impact on FDA/ISO compliance to ensure changes comply with company policy and procedures; identifies deliverables, supporting data, etc. needed to support approval of proposed change(s). As needed, works with departments to resolve issues before submitting change order to approval stage.
Identifies issues and assists in the resolution of ECO issues, while able to recognize high priority situations and take appropriate escalation actions, as needed, to ensure ECO initiator satisfaction and compliance with Inova procedures.
Uses judgement to determine when to consult with, or route ECOs to more senior members of the team.
Understands and applies working knowledge of more complex requirements and processes to the ECO process, including but not limited to Material Master creation, Bill of Materials (BOMs) and routings associated with manufactured products, quality inspection modules, electronic Device History Records (eDHR), product labeling requirements, etc.
Meets Inova’s document control performance standards, while ensuring satisfaction is maintained with all internal departments document control team supports
Maintains training requirements applicable to job role(s) and performance of associated activities in compliance with SOPs.
Performs other duties and projects as assigned to meet company and department objectives.
Complies with applicable Inova SOPs, ISO, FDA and other applicable Quality System regulations, as well as applicable Environmental Heath & Safety, Human Resources, and all other regulatory and administrative policies.
Reflects the values of Werfen and Inova in quality of work and in working relationships.

Qualifications

Minimum Education, Experience, Skills and Knowledge Education:

High school diploma or GED required.

Experience

3 or more years of experience working in a Document Control environment required; within a regulated manufacturing environment strongly preferred.
FDA Medical Device industry background preferred, particularly a good understanding of FDA/ISO regulations as they apply to Document Control.

Skills & Knowledge

Advanced knowledge of Adobe Acrobat and Microsoft Office suite, especially Word expertise, ex: formatting and track changes, required.
Excellent proofreading and writing skills required.
Experience with ERP document control software, preferably SAP required.
Able to communicate across various employee levels (i.e. diverse staff and management) required.
Able to identify actions necessary to achieve goals and to obtain results required; including meeting deadlines and performance goals.
Strong organization and quality-oriented skills, including time management , detail orientation and prioritization required.
Proven ability to multi-task, work independently while following written procedures and directions, excel under pressure, adapt and thrive in a fast-paced support role preferred.

Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement.

Werfen jobs

Document Control Specialist II