Job Description

For further inquiries regarding the following opportunity, please contact one of our Talent Specialists:
Hari at (224) 507-1278

Ragavendar at 224.394.4900

Title: Document Control Specialist
Location: Oneonta, N Y

Duration: 4 Months (Potential for extension or conversion based on project needs)

Locals preferred; non-locals acceptable if willing to relocate at their own expense.

Description of Work:

• Responsible for administration of quality management system documents and records required for Client Life Sciences processes.
• Responsible for initiation of document changes, distributions, notifications and fulfilling internal and external document distribution.
• Generates, reviews, and maintains quality system documents including procedures, work instructions, job aids, certificate of conformances, etc. in compliance with ISO 13485, ISO 9001, and 21 CFR 820 standards.
• Initiates Change Controls and Document Change Requests to update procedures and processes.
• Works within departments and with various departments to update processes and procedures.
• Assists in managing the document review and retention processes.
• Supports or leads continuous improvement initiatives for document control related processes.
• Supports other Quality Assurance functions as needed (internal audit, CAPAs, etc.)
• Other duties as required

Skills/Experience:

• Previous experience using ETQ or other Document Management software preferred
• Proficiency in Microsoft office
• Experience in ISO 9001 or other Quality System standards
• ISO 13485 and 21 CFR 820 Quality Management Systems knowledge highly preferred
• Must be detail oriented and accurate in execution of work
• Able to work well both independently and in a group setting

Top Skills Required:

• Proficient in Microsoft Office (Excel, Word, Outlook, etc.)
• Hands-on experience with ISO 9001 and other Quality System standards (preferred)
• Familiarity with ISO 13485 and 21 CFR 820 is highly preferred
• Experience with ETQ or similar Document Management Software (preferred)

Requirements:

• Associate's or Bachelor's degree with 2+ years' experience (manufacturing environment preferred).
• Strong MS Office skills , familiarity with ETQ or any Document Management System .

• Interview Rounds:
  • Round 1: Video Interview
  • Round 2: Onsite Interview

About us:

DivIHN , the 'IT Asset Performance Services' organization, provides Professional Consulting, Custom Projects, and Professional Resource Augmentation services to clients in the Mid-West and beyond. The strategic characteristics of the organization are Standardization, Specialization, and Collaboration.

DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status.

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