Computer System Validation Specialist

Agupdate; Wilmington, Northern (NC, KY); Hybrid; USD 85,000 - 110,000; Full time

Benefits offered by this job

Subsidized childcare

Benefits package

Job summary

Quality Chemical Laboratories (QCL) in Wilmington, NC seeks a Computer System Validation Specialist to lead and execute validation activities in a GxP environment. Responsibilities include authoring validation plans, IQ/OQ/PQ, RTM, data integrity assessments and deviation management, with collaboration across functions.

Qualified candidates have at least 2 years in CSV, experience drafting test scripts, and knowledge of 21 CFR Part 11 and GAMP practices.

Qualifications

• Two years' experience in Computer System Validation within a GxP environment.
• Experience writing computer system test scripts, validation protocols and summary reports.
• Knowledge of Regulatory Requirements, 21 CFR11, Data Integrity and GAMP practices.
• Strong analytical and problem-solving skills; ability to manage multiple sub-projects.

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 CSV Plan, IQ, OQ, PQ, Test Scripts, Summary reports, RTM, Periodic Review and Data Integrity Assessment.
• Track and resolve deviations/exceptions during qualification activities.
• Work with management to implement changes and upgrades; review vendor protocols and design specs; communicate approaches during audits.
• Review validated systems to assess need for further enhancements, validation, or upgrades/fixes.

Skills

Computer System Validation

GxP environment

Regulatory knowledge

Communication skills

Education

Advanced degree in Chemistry or related science

Tools

LabWare LIMS

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.