Laboratory Systems Qualification Specialist

Covance Inc Located in: Indianapolis,  Indiana
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JOB DESCRIPTION

Covance is hiring a Laboratory Systems Qualification Specialist to join their global team in Indianapolis, IN!

 

The Laboratory Systems Qualification Specialist is responsible to create Qualification and Validation documents and to submit them to appropriate reviewers and signatories in a timely manner in addition to the following:


• Responsible to create, review and sign off laboratory instruments qualification documents.
• 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 location, on compliance activities managed by Laboratory Compliance department.
• Responsible to maintain and store documentation in document repository.
• Responsible to recommend the necessary 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 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.
• Develops and maintains competency in Spreadsheet Validation process
• Develop expert knowledge in one of the main activities managed by Lab Compliance: Lab Instrument Qualification or Method Validation
• 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 lab management with a monthly report of activities.
• Other duties as assignResponsible to create Qualification and Validation documents and to submit them to appropriate reviewers and signatories in a timely manner.

• Responsible to create, review and sign off laboratory instruments qualification documents.
• 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 location, on compliance activities managed by Laboratory Compliance department.
• Responsible to maintain and store documentation in document repository.
• Responsible to recommend the necessary 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 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.
• Develops and maintains competency in Spreadsheet Validation process
• Develop expert knowledge in one of the main activities managed by Lab Compliance: Lab Instrument Qualification or Method Validation
• 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 lab management with a monthly report of activities.
• Other duties as assigned

BS, or MT (or equivalent); or AS, or MLT (or equivalent)

Required:
• If BS or MT(Medical Technologist) -one year experience
or
• If AS or MLT( Medical Laboratory Technologist)-two years experience

• Proven initiative and ability to work collaboratively within teams and achieve results.
• Has good customer service skills and great attention to detail.
• Fluent in English, French a good asset.
• Excellent written, verbal, and strong interpersonal skills.

 

Preferred:
• CLS bench experience and IT setting.
• Experience in instrument or systems Qualification or Validation.
• Exposure to 21CFR, Part 11
• IT technical background or competency
• Exposure to Computer Systems Validation (CSV) / Systems Development Lifecycle (SDLC) / GAMP

• Experience in use/maintenance of laboratory instrumentation or as an instrument Field Service Engineer (FSE)

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CRITICAL REQUIREMENTS

COMPANY INFORMATION

Covance Inc. is proud to be the only drug development company with a full range of research and development services—from lead optimization, to commercialization and life cycle management. Covance, headquartered in Princeton, NJ, is the drug development business of LabCorp with global operations in more than 30 countries.

JOB INFORMATION

Seniority Level:
Experienced - Not Management
Function:
  Quality,  R&D / Science,  Laboratory
Preferred Industry Background:
 
Managing a team of:
N/A
Required Travel:

Base Salary:
Confidential
Bonus:
Benefits:
Other Compensation: