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Documentation Manager

Chicago, IL 60601

Posted: 02/21/2021 Employment Type: Direct Hire Job Category: Clinical: Quality Job Number: 2746

Job Description


The Documentation Manager will be responsible for the execution of day-to-day quality project management activities related to the company-wide Quality Management System (QMS).

Responsibilities
  • Ensure regulatory compliance for all corporate policies, procedures, and work instructions.
  • Process SOP updates and review content to assist management approval.
  • Review and approve content for corporate and departmental procedures.
  • Author and update document control and training policies and procedures.
  • Ensure good manufacturing and documentation practices.
  • Provide compliance review of general quality system elements (e.g., change control, deviations, CAPAs).
  • Provide support for internal and external/regulatory audits.
  • Oversee all document change controls processed through the eDMS.
  • Manage and troubleshoot Veeva Systems (QualityDocs, Training, QMS) and maintain documentation thereof.
  • Configuration and validation of eDMS
  • Perform daily system administrative activities
  • Assist users in management of document hierarchies
  • Document change control
  • Laboratory/product development
  • Supplier and material qualification
  • Design history files
  • Commercial and developmental batches
  • Quality management systems (CAPA, Deviation, Product Change Control)
  • Quality agreements
  • Perform QualityDocs Training for new users and system administrators.
  • Provide support to compile training files for new employees, maintains training status of employees, and performs routine review of training compliance information.
  • Manage central filing system.
  • Manage Quality Control and Product Development inventory.
  • Issue and reconcile QC/PD laboratory notebooks.
  • Support and provide ideas for continuous improvement.
  • Participate in investigations as needed to address problems and assist in resolution.
  • Work closely with manufacturing personnel to meet the needs of operations.
  • Support Supplier Qualification Activities.
  • Initiate Supplier Change Assessments and provide support to impacted departments
  • Manage Supplier Qualification files
  • Provide Quality input in Device Design and Control Reviews.
  • Author, review and approve documents pertinent to the design development plan of devices
  • Manage the design history files
  • Serve as Quality Representative for Design Reviews
  • Manage GxP Resources in the client’ s Learning Center (Sales Training)
  • Manage Specification Committee Meetings.
  • Facilitate Specification Committee Meetings to ensure input is documented from cross functional team
  • Process new and revised in process and release specifications
  • Manage and develop Documentation Coordinator.
  • Other activities as assigned by the VP of Quality.

Qualifications
  • 5 - 7 years of experience maintaining documents within a QC or GMP/ISO-certified environment
  • Bachelor’ s degree in a relevant field is required
  • Knowledge of GMPs, documentation processes/requirements
  • Knowledge of current office software (e.g., Microsoft Office)
  • Experience in electronic control systems (e.g., Veeva, MasterControl)
  • Proficient with use of Microsoft Word, PDF Pro software, and Excel. Ability to create forms in Word, PDF Pro, and Excel, including controlled forms, as applicable.
  • Ability to work independently as well as in a team.
  • Competencies: Verbal and Written Communication skills, Independent Judgement, Teamwork and Collaboration, Attention to Detail, Flexibility, Time Management
  • Position may require periodic evening and weekend work, as necessary to fulfill obligations.

Meet Your Recruiter

Lisa Madden
EVP, Clinical Staffing

Lisa is an inspiring leader and mentor, driven by an inherent desire to help others and make a difference. An advocate for growth and professional development, Lisa brings 18 years of recruiting and business development experience to The Steely Group, and as Executive Vice President of Clinical Staffing, she oversees the direction and strategy of the Steely recruiting team.

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