Document Control Specialist
Document Control Specialist
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Salary Not Disclosed
1 Vacancy
Job Description
For further information please contact our Talent Specialist:
Infant at
Title: Document Control Specialist
Location: Oneonta NY
Duration: 9 Months
Working Hours: MF 8am 5pm
Position could be extended but that wont be determined until closer to November.
Top/Required Skills:
Associates or Bachelors and minimum of 2 years relevant work experience preferably in a manufacturing environment
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
Extremely organized with ability to use multiple resources in comparing documentation
Summary:
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.
Description of Work:
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
Minimum Qualifications:
Associate or bachelors Degree 2 years of work equivalent experience (work in a manufacturing environment is preferred).
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
About us: DivIHN the IT Asset Performance Services organization provides Professional Consulting Custom Projects and Professional Resource Augmentation services to clients in the MidWest 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.
Employment Type
Full Time
