Covance Lab Systems Qualification Specialist I in Indianapolis, Indiana
We are seeking a Lab Systems Qualification Specialist I to support our lab in Indianapolis. Duties will include the following:
Responsible to create, review and sign off laboratory instruments qualification documents.
Responsible to create, review and sign off laboratory instrument platform validation plans.
Responsible to create, review and sign off laboratory instrument product configuration specifications.
Responsible to create, review and sign off laboratory change requests for instruments.
Responsible to liaise with laboratory operation subject matter expert and instrument engineers to gather appropriate instrument qualification documents and certification/training documents from the vendor.
Responsible to train and support laboratory operation in all sites on instrument activities managed by LSQS 1 role.
Responsible to maintain and store documentation in designated documentation management system.
Responsible to recommend the necessary instrument procedural changes to ensure compliance; closes any gap that may exist as well as remediation plan where it is required.
With Managers, and other laboratory staff, completes all instrument documentation for regulatory compliance; through training and auditing of processes, ensures that compliance is achieved. Works with QA Staff to ensure that compliance is sustained.
Works with IT to help bring instruments into production.
Develops and maintains competency in spreadsheet assessment process.
Supports internal and external audit requests for site as needed.
Maintains highest standards for Covance CLS in area of regulatory compliance.
Participates in continuing education activities to keep knowledge current.
Demonstrates and documents competency as appropriate for regulatory requirements.
Maintains a high degree of safety awareness; observes Universal Precautions procedures.
Maintains areas/activities in inspection ready condition.
Maintains an up-to-date training file. Responsible for assuring that training is received and is documented prior to performing an assignment. Responsible for accuracy of training file and is accountable for any deficiencies found.
Demonstrates advanced use and knowledge of computer systems.
Provides laboratory management with a monthly report of activities at minimum.
Other duties as assigned.
Bachelor level degree or Medical Technologist diplomas.
1-2 of experience with laboratory instruments in regulated setting.
Strong knowledge of CAP/CLIA, GCP, and other applicable regulations.
Has good customer service skills and great attention to detail.
Medical Technologist background.
Instrument qualification or system validation experience.
Proven initiative and ability to work collaboratively within teams and achieve results.
Fluent in English, French a good asset
Excellent written, verbal, and strong interpersonal skills.
Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.
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