Associate Specialist Documentation
ManpowerGroup Global, Inc., Wind Lake, WI, United States
Title:
Quality Systems Documentation Specialist
Location:
Scarborough, Maine (100% Onsite)
Duration:
9 Months
Pay Range:
$25/hr to $30/hr (On W2)
Shift Time:
08:00am to 05:00pm
Job Summary
The position of Quality Systems Documentation Specialist within our Infectious Disease business unit located at Scarborough, Maine. In this role you will perform daily activities required to maintain the electronic Quality Management System (eQMS). This position is also responsible for and participating in the development, implementation, documentation, maintenance, and improvement of the business’s eQMS.
Job Responsibilities
Serve as site-level system administrator of the Change Control module and various other modules in Agile PLM
Support implementation of new modules or new software for the QMS
Manage system user profiles, user groups and role assignments and troubleshoot user issues
Develop, prepare, implement, and maintain quality system procedures according to applicable standards and regulations
Process change orders and requests to standard operating procedures (SOPs) and forms
Monitor the review and approval of documentation managed through the eQMS
Develop and coordinate training programs for new and current eQMS users
Recommend and initiate process improvement initiatives based on identified trends and key performance metrics
Work under defined timelines and be accountable for completing work within specified time periods
Other duties as required
Education
BS in Engineering, Chemistry, Bio‑Technology, Life Science or related discipline or equivalent combination of education and experience
Two to five years’ experience in the medical device industry, preferably in Quality or Document/Change Control
Demonstrated proficiency using Microsoft Office applications
Preferred Qualifications
Familiar with federal and other regulations, e.g. QSRs, ISO 13485, CMDR, IVDD/IVDR
Working knowledge of the General Provisions of 21 CFR Part 11 for Electronic Records and Electronic Signatures preferred
Advanced proficiency in the use of computerized systems to effectively administer the specialized eQMS applications, as well as efficiently utilize common office applications (Microsoft Office, Adobe). A working knowledge of Agile PLM or equivalent is preferred
Skilled in tasks associated with document handling, archiving and change management
We are looking for the candidate who is eligible to work with any employers without sponsorship.
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Quality Systems Documentation Specialist
Location:
Scarborough, Maine (100% Onsite)
Duration:
9 Months
Pay Range:
$25/hr to $30/hr (On W2)
Shift Time:
08:00am to 05:00pm
Job Summary
The position of Quality Systems Documentation Specialist within our Infectious Disease business unit located at Scarborough, Maine. In this role you will perform daily activities required to maintain the electronic Quality Management System (eQMS). This position is also responsible for and participating in the development, implementation, documentation, maintenance, and improvement of the business’s eQMS.
Job Responsibilities
Serve as site-level system administrator of the Change Control module and various other modules in Agile PLM
Support implementation of new modules or new software for the QMS
Manage system user profiles, user groups and role assignments and troubleshoot user issues
Develop, prepare, implement, and maintain quality system procedures according to applicable standards and regulations
Process change orders and requests to standard operating procedures (SOPs) and forms
Monitor the review and approval of documentation managed through the eQMS
Develop and coordinate training programs for new and current eQMS users
Recommend and initiate process improvement initiatives based on identified trends and key performance metrics
Work under defined timelines and be accountable for completing work within specified time periods
Other duties as required
Education
BS in Engineering, Chemistry, Bio‑Technology, Life Science or related discipline or equivalent combination of education and experience
Two to five years’ experience in the medical device industry, preferably in Quality or Document/Change Control
Demonstrated proficiency using Microsoft Office applications
Preferred Qualifications
Familiar with federal and other regulations, e.g. QSRs, ISO 13485, CMDR, IVDD/IVDR
Working knowledge of the General Provisions of 21 CFR Part 11 for Electronic Records and Electronic Signatures preferred
Advanced proficiency in the use of computerized systems to effectively administer the specialized eQMS applications, as well as efficiently utilize common office applications (Microsoft Office, Adobe). A working knowledge of Agile PLM or equivalent is preferred
Skilled in tasks associated with document handling, archiving and change management
We are looking for the candidate who is eligible to work with any employers without sponsorship.
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