Computer System Validation Specialist

Vance Airscoop; Wilmington (NC); On-site; USD 85,000 - 110,000; Full time

Job summary

Quality Chemical Laboratories (QCL) in Wilmington, NC seeks a Computer System Validation Specialist with GxP experience to lead validation projects for laboratory instruments and systems.

The role includes drafting IQ/OQ/PQ, validation plans, RTMs, data integrity assessments, and collaborating with vendors. Strong focus on audits and continuous improvement; team-oriented environment.

Qualifications

• Two years of CS validation experience in a GxP environment.
• Experience 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.

Responsibilities

• Lead and perform computer system validation projects per ISPE GAMP 5.
• Prepare IQ/OQ/PQ, test scripts, RTM, and validation summaries.
• Track and resolve deviations during qualification activities.
• Coordinate with management on system upgrades and vendor reviews.
• Communicate validation approaches during audits.
• Review validated systems for enhancements or fixes.

Skills

CS Validation

GxP environment

Regulatory knowledge

21 CFR 11

Data integrity

Problem solving

Multitasking

Communication

Education

Advanced degree in Chemistry or related science

Tools

LabWare LIMS

Validation software

Job description

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

Responsibilities:

• Performs and leads 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. Documentation includes Computer System Validation Plan, Risk Assessment, IQ, OQ, PQ, Test Scripts, Summary reports, Requirements Traceability Matrix (RTM), Periodic Review of Computer Systems, and Data Integrity Assessment.
• 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

Quality Chemical Laboratories (QCL) is a rapidly growing pharmaceutical testing and manufacturing lab in Wilmington, NC. We are seeking highly motivated candidates for multiple positions throughout the company in the areas of analytical data review, LabWare LIMS development/configuration/validation, Document Control, Computer System Validation and Data Integrity Specialists, Scientists (all levels) with experience in Mass Spec, LC, GC, QC compendial testing, Wet Chemistry, Microbiology, Sterility, Synthetic Chemistry, Biotech, Pharmaceutical Formulation and Manufacturing (requires knowledge of manufacturing equipment), Validation Engineers, Metrology, Report Generation, Sample Log-In Associates, and HVAC Technicians. Special attention given to candidates with an advanced degree in Chemistry or related science and experience in method development/validation. Special consideration also given to experienced GMP data reviewers.

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.