Quality Assurance MasterControl Administrator
POSITION SUMMARY
The Quality Assurance-MasterControl Administrator is responsible for the management and maintenance of quality systems in the All-Access Configuration within MasterControl.
ESSENTIAL FUNCTIONS
Reasonable Accommodations Statement -To accomplish this job successfully, an individual must be able to perform, with or without reasonable accommodation, each essential function satisfactorily. Reasonable accommodations may be made to help enable qualified individuals with disabilities to perform the essential functions.
oConfigure InfoCard types, Vaults, Lifecycles, Routes, Roles, PDF Publishing settings and other required configuration components for the MasterControl Documents Module as defined by NewLink Genetics and the Quality Unit.
oConfigure Courses, Job Codes, Trainer and Trainee InfoCards in MasterControl.
oFacilitate movement of documents through their appropriate approval routes and lifecycles, including ensuring the appropriate training is assigned to all trainees in MasterControl.
oConfigure and generate scheduled and impromptu reports from the MasterControl database.
oPrepare and perform new-hire training regarding MasterControl.
oField end-user and technical support questions regarding MasterControl.
oLead projects for the configuration and validation of modules available in the All-Access Configuration of MasterControl.
oCreate and update document control tracking databases.
oConfigure and test Quality Event Modules (Deviation, Change Control, CAPA, and OOS) in MasterControl.
oPerform other Quality Assurance duties as required.
POSITION QUALIFICATIONS
oCommunication, Oral - Ability to communicate effectively with others using the spoken word.
oCommunication, Written - Ability to communicate in writing clearly and concisely.
oOrganized - Possessing the trait of being organized or following a systematic method of performing a task.
oDetail Oriented - Ability to pay attention to the minute details of a project or task.
oSelf Motivated - Ability to be internally inspired to perform a task to the best of ones ability using his or her own drive or initiative.
oAdaptability - Ability to adapt to change in the workplace.
oCollaboration - Works in collaboration with others and small teams to achieve goals
oTime Management - Ability to utilize the available time to organize and complete work within given deadlines.
oProject Management - Ability to organize and direct a project to completion.
SKILLS & ABILITIES
oEducation:
Bachelor's Degree (four year college or technical school):
Preferred
o
Experience:
At least 2 years experience and/or training with MasterControl is a plus.
oComputer Skills:
Experience with MasterControl Quality Events modules is a plus.
oFluent in Microsoft Office software.
oOther Requirements:
Experience with FDA 21 CFR Part 11 requirements is a plus.
oExperience with computer system validation is a plus.
Estimated Salary: $20 to $28 per hour based on qualifications.
The Quality Assurance-MasterControl Administrator is responsible for the management and maintenance of quality systems in the All-Access Configuration within MasterControl.
ESSENTIAL FUNCTIONS
Reasonable Accommodations Statement -To accomplish this job successfully, an individual must be able to perform, with or without reasonable accommodation, each essential function satisfactorily. Reasonable accommodations may be made to help enable qualified individuals with disabilities to perform the essential functions.
oConfigure InfoCard types, Vaults, Lifecycles, Routes, Roles, PDF Publishing settings and other required configuration components for the MasterControl Documents Module as defined by NewLink Genetics and the Quality Unit.
oConfigure Courses, Job Codes, Trainer and Trainee InfoCards in MasterControl.
oFacilitate movement of documents through their appropriate approval routes and lifecycles, including ensuring the appropriate training is assigned to all trainees in MasterControl.
oConfigure and generate scheduled and impromptu reports from the MasterControl database.
oPrepare and perform new-hire training regarding MasterControl.
oField end-user and technical support questions regarding MasterControl.
oLead projects for the configuration and validation of modules available in the All-Access Configuration of MasterControl.
oCreate and update document control tracking databases.
oConfigure and test Quality Event Modules (Deviation, Change Control, CAPA, and OOS) in MasterControl.
oPerform other Quality Assurance duties as required.
POSITION QUALIFICATIONS
oCommunication, Oral - Ability to communicate effectively with others using the spoken word.
oCommunication, Written - Ability to communicate in writing clearly and concisely.
oOrganized - Possessing the trait of being organized or following a systematic method of performing a task.
oDetail Oriented - Ability to pay attention to the minute details of a project or task.
oSelf Motivated - Ability to be internally inspired to perform a task to the best of ones ability using his or her own drive or initiative.
oAdaptability - Ability to adapt to change in the workplace.
oCollaboration - Works in collaboration with others and small teams to achieve goals
oTime Management - Ability to utilize the available time to organize and complete work within given deadlines.
oProject Management - Ability to organize and direct a project to completion.
SKILLS & ABILITIES
oEducation:
Bachelor's Degree (four year college or technical school):
Preferred
o
Experience:
At least 2 years experience and/or training with MasterControl is a plus.
oComputer Skills:
Experience with MasterControl Quality Events modules is a plus.
oFluent in Microsoft Office software.
oOther Requirements:
Experience with FDA 21 CFR Part 11 requirements is a plus.
oExperience with computer system validation is a plus.
Estimated Salary: $20 to $28 per hour based on qualifications.
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