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Master Control/Document Control Specialist - Direct Hire

Company: USDM Life Sciences
Location: Malvern
Posted on: May 28, 2023

Job Description:

Job Title: Master Control/Document Control Specialist - Direct Hire Job Function: Quality Consultant Location: Malvern, PA - Hybrid About USDM USDM Life Sciences is a premier consulting company with 20+ years of experience assisting heavily regulated biotech, medical device, and pharmaceutical companies with their GxP technologies to accelerate growth. Our deep domain knowledge and technology expertise in life sciences business processes are what sets us apart. From strategy to implementation and adoption, we have delivered thousands of GxP projects globally. As part of the USDM team, you have the opportunity to work with cutting edge technologies through our many partnerships with companies like Microsoft, Google, Oracle, DocuSign, Box, and many more. From molecule to market, you will help connect technology, people, and data in new ways to generate real-time insights to improve business outcomes for USDM's clients. Are you ready to make an impact and drive real digital transformation in life sciences? Founded in Santa Barbara in 1999, USDM has grown to a progressive, global company with 300+ remote employees and offices throughout the US, Canada, and Germany. Nature and Scope of Job USDM is hiring a Master Control Document Control Specialist for our client. This role is a direct hire position. Under guidance of the Director, Quality Assurance, the Document Control Specialist (DCS) maintains the company documentation including QMS processes and associated quality records in compliance with Federal and international regulations by effectively utilizing the Company's electronic document management system (EDMS). The DCS manages document changes (change control) according to Standard Operating Procedures, throughout the full life cycle of the document. The DCS works in a collaborative environment to meet the needs of internal and external customers effectively and efficiently. The DCS ensures documents are controlled, and that use of obsolete documents is prevented. Primary Responsibilities The Document Control Specialist is responsible for managing the document control process from document creation, through collaboration, approval, release, and ultimately to retirement:* Serves as the Master Control System Administrator SME and provides training/guidance to system end-users as needed, and in instructor-led settings.* Implements and streamlines document workflows.* maintains training materials and records for the various levels of system users.* Prioritizes Change Control activities and drives Change Notices to completion using metrics and periodic reporting.* Compiles CN and Training process metrics.* Identifies negative data trends and escalates as needed.* Manages the release and control of updates to policies, procedures, instructions, etc.* Manages Quality Records and programs including: Vendor Management and Approved Supplier List, Organization Chart, GMP Signature Logbook, Environmental Monitoring, electronic and off-site document archiving* Communicates effectively with cross-functional and external stakeholders on matters related to documentation systems* Manages the inter-company Change Control/ECN process* Assists in third-party ISO and GMP audits* Implements best practice solutions to improve and maintain the QMS documents and CN process* Assumes other responsibilities as assigned by functional manager Qualifications "Hands-on", self-motivated and detail oriented individual Ability to triage multiple priorities Strong focus on customer service High ethics and integrity Outstanding organizational skills and ability to work systematically and cross-functionally, driving assigned tasks to completion Advanced user of Microsoft Office Suite, Master Control, Adobe, SharePoint, and general computer skills. Must have Master Control document system experience in Administrator role. Highly organized, detail oriented with solid analytical and technical writing skills. Ability to identify potential problems and propose viable solutions. Strong oral and written communication and interpersonal skills with the ability to work across functions and departments. Ability to take direction and multi-task in a dynamic environment. Able to work effectively both independently and as part of a team. Education & Certifications Associate Degree and a minimum of 3 years of hands-on work experience in a regulated (GMP, ISO) environment as a Documentation Control Specialist. At the hiring managers discretion, an equivalent combination of education, training and experience may be substituted. Working Conditions The working conditions described here are representative of those that must be met by an employee to successfully perform the essential responsibilities and functions of the job and are not meant to be all inclusive. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential responsibilities and functions of the job. Unless reasonable accommodations can be made, while performing this job the staff member shall: Prolonged periods of sitting or standing at a desk and working on a computer in an environmentally controlled home office environment. Must be able to lift up to 15 pounds at times. Operate other office productivity machinery, such as a calculator, scanner, or printer. Frequently communicate with stakeholders via telephone, email, or instant message. Must be able to exchange accurate information in these situations. Equal Opportunity Statement USDM Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Disclaimer This job description is intended to describe the general nature and the level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. USDM Life Sciences reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. PDN-9935549c-1af0-4677-9340-adc1396ad2d0

Keywords: USDM Life Sciences, Omaha , Master Control/Document Control Specialist - Direct Hire, Other , Malvern, Nebraska

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