Computer System Validation Specialist

5 days ago


Wilmington, North Carolina, United States Quality Chemical Laboratories Full time
Job Title: Computer System Validation Specialist

Quality Chemical Laboratories (QCL) is a leading pharmaceutical testing and manufacturing laboratory in Wilmington, NC, seeking a qualified candidate for the position of Computer System Validation Specialist.

Responsibilities:
  • Perform and lead computer system validation projects related to authoring and executing validation documentation for laboratory instruments/equipment and systems according to the ISPE GAMP 5 Validation Life Cycle.
  • Track and resolve deviations/exceptions during qualification activities.
  • Work with company management to implement changes and upgrades to computer systems.
  • Work with vendors on purchasing and planning for new lab equipment/software upgrades, review vendor protocols/design specifications.
  • Communicate Computer System Validation approaches and requirements during audits.
  • Review validated systems to assess need for further enhancements, validation, or system upgrades/fixes.
Qualifications:
  • Two (2) years of experience with Computer System Validation in GxP environment (preferably pharmaceutical industry).
  • Experience in writing computer system test scripts, validation protocols and summary reports.
  • Knowledge of Regulatory Requirements, 21CFR11, Data Integrity Guidance, GAMP and industry best practices for validation to complete tasks.
  • Proficient in analyzing and troubleshooting problems, identifying solutions, recommending, and implementing methods, procedures and/or techniques for resolution.
  • Capable of managing multiple sub-projects, duties and tasks.
  • Effective at communicating clearly and concisely, both orally and in writing.
  • Able to work both independently and as a member of a cross-functional project team.

QCL offers competitive salaries commensurate with experience and an excellent benefits package, as well as great potential for career advancement and leadership in a rapidly growing company. We now also offer subsidized childcare at our newly acquired childcare facility.

QCL is an equal opportunity employer.


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