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Apex Life Sciences

Laboratory Equipment Qualification Lead

Post Date:Oct 11, 2018Type:Contractor
Start Date:10/11/2018Salary:
Location:US-MA-Cambridge Job Reference:903569
Skills:
 

Job Description:

Responsibilities:

Generation and Approval of Glasswasher Maintenance Procedure

  • One (1) Cleaning Cycle/Recipe
  • Two (2) Load Patterns

Equipment/Instrument Criticality Assessment

  • Calibration of Critical Equipment

• Generation and Approval of Commissioning Protocol

• Execution of Commissioning Protocol / Discrepancy Generation and Resolution

• Generation/Approval of Commissioning Final Report

• Execution of Vendor Installation/Operation Qualification I/OQ

• Generation and Approval of Supplemental I/OQ protocol

• Execution of I/OQ Protocols / Discrepancy Generation and Resolution

• Generation/Approval of I/OQ Final Report

Generation of Cleaning Verification Protocol

  • Manual Soiling of Glasswasher Equipment with worst case soil
  • 1X Cleaning Verification for all Load Patterns

Skills:

Laboratory Equipment Qualification experience in a GMP environment, Change Control, URS, IQ, OQ, and Requalification.

Education:

Bachelor's Degree in relevant field. 2-4 relevant experience in a GMP environment.

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.





Contact Information
Apex Life Sciences



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