Quality Assurance Document Control Specialist

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Description

HealthTrust, an affiliated company of HCA Healthcare, is committed to performance improvement across the healthcare continuum. We offer an array of medical, dental, and vision packages as well as several add-on perks to make your rewards and benefits customizable to your needs. Some unique offerings include:

• Tuition Reimbursement/Assistance Programs
• Student Loan Repayment
• Student Loan Repayment Assistance
• Paid Personal Leave
• 401k (100% annual match – 3% to 9% of pay based on years of service)
• Employee Stock Purchase Program (ESPP)
• Identity Theft Protection discounts
• Auto, Home, and Life Insurance options
• Adoption Assistance

Job Summary

The primary purpose of this position is to work within the Quality Assurance department in several key roles relating to documentation maintenance, document control functions, data analysis, and report/metric generation. This position is critical in ensuring compliance with 21 CFR Part 820, 21 CFR Part 11 and ISO 13485 requirements. The QA Document Control Specialist reports to QRA management.

Responsibilities

• Control and maintain Quality Management System functions:
  • Maintain documentation and records in Electronic Document Management System (EDMS).
  • Serve as administrator for EDMS including:
    • Creating and maintaining colleague accounts and profiles in EDMS.
    • Administer co-worker training on the documentation process and tools (i.e. Q-Pulse or other EDMS) per their job requirements.
    • Assist with EDMS upgrades and file migrations.

• Manage Documentation Control function and processes including but not limited to:
  • Maintain master document list.
  • Prepare and revise policies, procedures, work instructions, forms and reports.
  • Route documents for approval based on established workflow and approval requirements.
  • Ensure document approvals are obtained in a timely manner prior to publishing.
  • Route documents for regular review as specified within the Document Control system and established procedures.
  • Maintain accurate records of document lifecycle-creation, approval, revision, obsolescence, and removal from use.
  • Ensure documents are archived and/or destroyed as appropriate based on defined retention times.
  • Serve as liaison between Quality Assurance and other departments and ensure compliance with documentation control requirements.
• Prepare reports on Documentation Control and other processes for trending purposes.
• Assist with internal and external audits to ensure that requested documents are readily available to auditors.
• Perform audits of training records and maintain training records in compliance to regulatory requirements.
• Assist QRA management, as requested.
• Promote Good Manufacturing Practices (GMPs) and Quality Systems.
• Complete other related responsibilities, as requested.

Knowledge, Skills and Abilities

• Knowledgeable of Microsoft Word, Outlook, and Excel.
• Excellent interpersonal skills and communication.
• Ability to work independently in fast-paced environment with minimal supervision.
• Ability to adapt to constant change and work effectively in abstract environment.
• Ability to be self-motivated and detail oriented.

Qualifications

Education

• Associates degree or higher

Experience

• Technical writing experience.
• Experience with data analysis.
• Basic understanding of Good Manufacturing Practices (GMP’s) and Quality Systems.
• Previous Quality Assurance experience

We are a subsidiary of HCA Healthcare, a comprehensive healthcare network where 280,000 people across more than 2,000 care facilities are all committed to creating a positive impact every day. It’s an organization that exists to give people healthier tomorrows. HCA Healthcare has been continually named a World's Most Ethical Company by Ethisphere since 2010.

Be a part of an organization that invests in you. We are actively reviewing applications for our Contract Administrator opening. Highly qualified candidates will be promptly contacted for interviews. Submit your application and help us raise the bar in patient care!

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

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