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Document Control Associate

US-Lawndale

Overview

The Document Control Associate manages quality documentation, processes and records at Critical Innovations, applying best practices from within the field of quality control to ensure that the Quality Management System remains effective and up-to-date.

The Document Control Associate will assist in the management and implementation of the Quality Management System to ensure compliance with ISO 13485, the FDA’s Quality System Regulations 21 CFR Part 820, including compliance with FDA Regulatory requirements for combination products that are either device- or drug-led (CDRH or CDER) encompassing cGMP for pharmaceutical products 21CFR Parts 210 and 211.

The Document Control Associate will provide additional support to the Quality Management System’s activities as assigned at the discretion of management.

This is an on-site, full-time position.

Reports to:

Vice President of Quality Assurance & Regulatory Affairs.

Duties and Responsibilities:

The Document Control Associate’s responsibilities typically involve:

  • Performing and documenting work in compliance with ISO 13485, the FDA’s Quality System Regulations and cGMP.
  • Assisting with implementing and maintaining a quality system that is compliant with ISO 13485 and the FDA’s Quality System Regulation requirements.
  • Assisting with management of Document Control, Document Change Orders, Quality Records and Design History Files.
  • Maintain Quality System documents and records (hard copy and electronic format).
  • Management of Document Change Orders for approval, release and implementation, including notification of external vendors where appropriate.
  • Review Document Change Orders for accuracy and completeness.
  • Format documents submitted for Document Change Orders (revision or original release).
  • Management of Document History Records.
  • Management of Quality Document Logs.
  • Coordinate destruction of expired records and documents.
  • Ensure that controlled copies of latest approved Quality documents are managed, updated and available at points of use.
  • Assist Project Managers with update of Design History Files.
  • Assist with formal audits through retrieval and provision of requested documents in a timely manner and assist with completion of audit reports.
  • Commonly exercise decision-making and discretion in performing job-related tasks.
  • Additional support for the Quality Management System activities as assigned.
  • On a daily basis, assess overall workload for any area that needs help, and assist coworkers and provide backup as needed without being reassigned by management.

Skills and Experience:

  • Excellent communication both written and orally.
  • Excellent problem-solving and critical-thinking skills.
  • Excellent attention to detail.
  • Ability to work independently with ability to complete routine tasks with little or no supervision.
  • Ability to work in a cross-functional team environment.
  • Ability to edit and proof documents.
  • Experience of ISO 13485 Quality Management Systems.
  • Experience of FDA’s regulations and cGMP as it pertains to Document Control.
  • Proficient with Microsoft Office Suite.
  • Self-motivated with strong time-management skills and capable of working with minimal supervision.
  • Highly organized and detailed oriented.
  • Able to perform light to moderate lifting and ability to sit at a computer for terminal for an extended period of time.

Education and Training:

  • Required:
    • Bachelor’s degree (BA/BS),

and/or

  • One year or more experience in a Quality Assurance/Document Control role in the Medical Device, cGMP-regulated Pharmaceutical environment or related field is preferred.
  • Working knowledge of the FDA’s QSR 21 CFR Part 820, ISO 13485 and cGMP as it pertains to document control.
  • Authorization to work in the United States indefinitely without restriction or sponsorship.

Critical Innovations is an Affirmative Action/Equal Employment Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, protected veterans' status, or any other characteristic protected by law.

To conform to U.S. Government Department of Defense regulations, you must be a U.S. citizen, lawful permanent resident of the U.S., protected individual as defined by 8 U.S.C. 1324b(a)(3), or eligible to obtain the required authorizations from the U.S. Department of State.

Benefits:

  • 401(k) Safe Harbor Plan
  • Healthcare Insurance: Medical, Dental and Vision
  • Other Insurance: Life Insurance and Long-Term Disability (LTD) Insurance
  • Time Off: Paid Time Off (PTO), Paid Sick Leave, Paid Holidays, and Paid Bereavement Leave
  • Tuition Reimbursement Program
  • Performance Bonus
  • Flexible Schedule
  • Lunches, Snacks, Events

Schedule:
Monday to Friday

Salary
$55,000 - $75,000 per year

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