Documentation Specialist
Akkodis, Scarborough, ME, United States
Akkodis is seeking an
Associate Specialist Documentation
for an
8-month contract
with a client in
Scarborough, ME 04074 (Onsite) .
Title:
Quality Systems Documentation Specialist
Location:
Scarborough, ME 04074 (Onsite)
Duration:
8 months w/ possibility of extension
Pay Rate:
$28-30/hr (The rate may be negotiable based on experience, education, geographic location, and other factors).
Shift:
Fully on-site, 8 am to 5 pm
Job Description 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.
Basic Qualifications and 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.
Equal Opportunity Employer/Veterans/Disabled
Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, an EAP program, commuter benefits, and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.
To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit https://www.akkodis.com/en/privacy-policy.
The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:
The California Fair Chance Act
Los Angeles City Fair Chance Ordinance
Los Angeles County Fair Chance Ordinance for Employers
#J-18808-Ljbffr
Associate Specialist Documentation
for an
8-month contract
with a client in
Scarborough, ME 04074 (Onsite) .
Title:
Quality Systems Documentation Specialist
Location:
Scarborough, ME 04074 (Onsite)
Duration:
8 months w/ possibility of extension
Pay Rate:
$28-30/hr (The rate may be negotiable based on experience, education, geographic location, and other factors).
Shift:
Fully on-site, 8 am to 5 pm
Job Description 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.
Basic Qualifications and 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.
Equal Opportunity Employer/Veterans/Disabled
Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, an EAP program, commuter benefits, and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.
To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit https://www.akkodis.com/en/privacy-policy.
The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:
The California Fair Chance Act
Los Angeles City Fair Chance Ordinance
Los Angeles County Fair Chance Ordinance for Employers
#J-18808-Ljbffr