Role: Document Control Specialist

Shift 8AM- 5PM MON- FRI

Responsibilities:

• The Document Control Specialist receives reviews and classifies incoming quality systems records and supporting materials such as Validations, Batch Records, Lab Notebooks etc.
• Reviewing and processing change requests for new documents and revisions to existing document. This includes processing, organizing, and maintaining document control administrative functions of the product lifecycle management application to ensure applicability to governing procedures and regulations.
• Creates files, labels and barcodes incoming records and prepares them for storage based on the company’s record retention policy.
• Manages verbal and written requests for records.
• Locates, retrieve, deliver and follow up on checked out records as requested.
• Performs technical and clerical assignments involving data entry, proofing and other administrative duties.
• Assists in the documentation of key processes and departmental procedures.
• Work on continuous improvement projects as assigned by management.
• Delivers training and Assists in the supervision of junior personnel.
• Demonstrates a sense of urgency and timeliness for assuring optimal record management.
• Demonstrates commitment to the development, implementation and effectiveness of Alere Quality Management System per ISO, FDA, and other regulatory agencies.
• Understands and is aware of the quality consequences which may occur from the improper performance of their specific job; has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities.
• Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices; build productive internal/external working relationships.
• Carries out duties in compliance with established business policies.
• Other duties as assigned, according to the changing needs of the business.
• Ensure compliance within the organization as it pertains to documentation and records management
• Provide support as a Content Manager of various PD Electronic Document Management Systems (e.g. Document Management) Records Management Systems
• Generate metrics and support communication (i.e. upcoming periodic reviews, schedule for off-site storage and/or destruction)

Key Responsibilities:

• Manages day-to-day operation and compliance of the Records Center, including issuance, archival, charge-outs, and reconciliation of GMP physical records including but not limited to equipment logbooks, laboratory notebooks, manufacturing batch records, and equipment qualification records.
• Coordinates offsite record storage and recall activities with Iron Mountain.
• Serves as Records Management System (RMS) Subject-Matter-Expert (SME) to enable successful execution of workflows within the system.
• Identifies opportunities for continuous improvement including need for system enhancements through partnership with Global Quality Systems and Information Technology.
• Supports implementation of global quality system initiatives, including but not limited to electronic documentation systems and processes.
• Utilize the Records Management System to manage hardcopy GMP documents submitted for retention and archival.
• Provide support for procedural documentation requests, records management, issuance of logbooks/notebooks issuance, tracking and reconciliation for the NBR site.
• Completes routine tasks with little or no supervision.
• Requires moderate direction to complete more complex tasks
• Adherence to core behaviors
• Knowledge and proficiency of electronic document control systems.
• Knowledge of engineering drawings, change control and incoming inspection processes will enhance execution of the deliverables.
• Proficiency with Outlook, Word, Excel, PowerPoint, Acrobat, and other software tools
• Strong verbal, written, organizational, time management and interpersonal skills

Education/Experience:

• Nearly 2 years of records mgmt. & document coordination experience using an electronic documentation system, preferably Veeva Quality Docs.
• Prior experience training end users on how to use quality systems and comply with procedures.
• Prior experience supporting closure of investigations and corrective actions.

Job Types: Full-time, Contract

Salary: $22.50 per hour

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

COVID-19 considerations:
Candidate must be vaccinated

Ability to commute/relocate:

• Irving, TX 75038: Reliably commute or planning to relocate before starting work (Required)

Education:

• High school or equivalent (Required)

Experience:

• Document management: 2 years (Required)

Shift availability:

• Day Shift (Preferred)

Work Location: One location

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