Computer System Validation Specialist

QUALITY CHEMICAL LABORATORIES; Wilmington (NC); Presencial; USD 70.000 - 100.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Competitive salary

Excellent benefits

Subsidized childcare

Career advancement opportunities

Descripción de la vacante

Quality Chemical Laboratories (QCL) in Wilmington, NC is seeking a Computer System Validation Specialist to lead validation projects across laboratory instruments and systems in a GxP environment. You will author validation documentation, execute test scripts, and ensure data integrity in accordance with ISPE GAMP 5 guidelines.

The role requires 2 years of relevant CS Validation experience, strong documentation skills, and the ability to work with internal teams and vendors.

Formación

• Two years of experience with Computer System Validation in a GxP environment.
• Experience in writing computer system test scripts, validation protocols and summary reports.
• Knowledge of regulatory requirements (21 CFR Part 11) and data integrity guidance.
• Ability to analyze, troubleshoot, and implement solutions.
• Capability to manage multiple sub-projects and collaborate cross-functionally.

Responsabilidades

• Performs and leads computer system validation projects including documentation such as Validation Plans, IQ/OQ/PQ, test scripts, RTM, and data integrity assessments.
• Track and resolve deviations/exceptions during qualification activities.
• Collaborate with management on changes and upgrades to computer systems.
• Coordinate with vendors for equipment/software upgrades and review protocols.
• Communicate validation approaches during audits and review systems for enhancements.

Conocimientos

Computer System Validation

Documentation Writing

Analytical thinking

Communication skills

Project multitasking

Educación

Advanced degree in Chemistry or related science

Herramientas

LabWare LIMS

Descripción del empleo

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.