Position Details
Document Control Specialist Apply
For further information please contact our Talent Specialist:
Infant at 224 507 1261
Title: Document Control Specialist
Location: Oneonta, NY
Duration: 9 Months
Working Hours: M-F, 8am - 5pm
Description
-Interview Process: Phone screen and then onsite interview
-Position could be extended, but that won't be determined until closer to November.
-Position could be extended, but that won't be determined until closer to November.
-This position is to assist with a major project in Oneonta with changes to the documentation system and preparing for an audit.
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 bachelor's 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
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 bachelor's 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 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.
