Qualitychemlabs
Computer System Validation Specialist
Qualitychemlabs, Wilmington, North Carolina, United States, 28412
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Computer System Validation Specialist
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Quality Chemical Laboratories 1 month ago Be among the first 25 applicants Join to apply for the
Computer System Validation Specialist
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Quality Chemical Laboratories 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.
recblid 1ip2745a11zmfw3kvvssxft76g1ozy
Seniority level
Seniority level
Associate Employment type
Employment type
Full-time Job function
Job function
Information Technology Industries
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Computer System Validation Specialist
role at
Quality Chemical Laboratories 1 month ago Be among the first 25 applicants Join to apply for the
Computer System Validation Specialist
role at
Quality Chemical Laboratories 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.
recblid 1ip2745a11zmfw3kvvssxft76g1ozy
Seniority level
Seniority level
Associate Employment type
Employment type
Full-time Job function
Job function
Information Technology Industries
Appliances, Electrical, and Electronics Manufacturing Referrals increase your chances of interviewing at Quality Chemical Laboratories by 2x Get notified about new Computer Specialist jobs in
Wilmington, NC . Wilmington, NC $100,000.00-$120,000.00 5 days ago Wilmington, NC $83,750.00-$115,156.00 1 month ago Wilmington, NC $80,000.00-$140,000.00 4 days ago Embedded Software Engineer- FULLY REMOTE
AI Technical Product Engineer (Remote Eligible, U.S.)
Wilmington, NC $80,000.00-$140,000.00 4 days ago CNC Electro-Mechanical Maintenance Technician - 2nd shift
Software Engineer - I&C (Instrumentation & Controls)
Wilmington, NC $150,000.00-$180,000.00 2 days ago Wilmington, NC $80,000.00-$140,000.00 1 day ago CNC Electro-Mechanical Maintenance Technician - 2nd shift
Greater Wilmington Area $40.00-$50.00 3 days ago Were unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr