Document Control Specialist I

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POSITION SUMMARY
This Document Control Specialist I is responsible for executing the change control processes to ensure standardization, accuracy, and completeness of documents prior to release. Represents Quality Assurance (QA) and interacts with cross-functional departments to provide quality system guidance. They are responsible for maintaining Master Control and performing tasks related to continuous improvement of this document control system Stakeholder in the development, implementation, and continued improvement of quality systems within the QA department.

ESSENTIAL DUTIES & RESPONSIBILITIES
• Create and maintain Document Control quality system procedures and quality documents
• Maintain controlled copies of quality documents in the files and in electronic databases
• Index, file, archive, and manage off-site storage-controlled copies of quality records and other corporate records
• Execute change control processes ensuring accuracy and completeness of documents prior to release
• Collaborate with other teams in the timely processing of protocols, reports and other design control and process validation activity
• Guide cross-functional teams in good documentation practices
• Support maintenance of design history files, device master records, and technical files
• Support Operations in part number control and BOM maintenance in the ERP system as a result of an approved change order
• Provide training to new and current employees on how to use MasterControl for processing change orders
• Provides QA review of calibration and preventive maintenance records, scanning, and archival.
• Facilitates document retrieval during regulatory inspections
• Support quality system audits by providing requested change orders.
• Other duties may be assigned

POSITION REQUIREMENTS

Education and Experience
• Associates degree or higher is preferred
• Experience working in an FDA regulated environment and in the IVD industry is preferable.
• 1-2 years of document control experience or similar industry experience is preferable.
• Experience with Master Control a plus.
• Experience with ERP system a plus.

Skills – Technical
• Proficient in Microsoft Office, especially Word and Excel, for editing and tracking documents.
• Experience with Document and Change Control electronic systems (preferably Master Control)
• Experience working with cross-functional areas (e.g., Manufacturing, Operations)

Skills – General
• Must be a hands-on, self-directed, detail oriented and conscientious individual
• Complete work in a timely, accurate and thorough manner
• Proven ability to prioritize responsibilities in a high pressure, dynamic, multi-tasking environment.
• Strong time management and organizational skills in a dynamic, constantly changing environment
• Ability to work effectively, exhibit a professional manner and establish constructive working relationships

CERTIFICATIONS, LICENSES, REGISTRATIONS (if applicable)
• None

SUPERVISORY RESPONSIBILITIES (if applicable)
• None

WORK ENVIRONMENT
The essential functions of the job are usually performed in an environmentally controlled facility where the noise level in the work environment is usually moderate. This position may involve a combination of office and biotechnology laboratory environments. The employee may be exposed to hazardous chemicals, blood borne pathogens and automated equipment.

While performing the job duties, the employee is regularly required to sit; reach with hands and arms and talk or hear. The employee is frequently required to stand and walk. The employee may sometimes be required to lift and/or move up to 35 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision and ability to adjust focus.