* In this role, you will collaborate with cross-functional teams to ensure systems meet quality ... Responsibilities: * pply quality standards and cGMP requirements to validate computer systems ...
New
* In this role, you will collaborate with cross-functional teams to ensure systems meet quality ... Responsibilities: * pply quality standards and cGMP requirements to validate computer systems ...
New
* In this role, you will collaborate with cross-functional teams to ensure systems meet quality ... Responsibilities: * pply quality standards and cGMP requirements to validate computer systems ...
New
Princeton, NJ ยท On-site
GAMP 5 Risk-Based validation / ICH Q9 hands-on implementation knowledge * Manufacturing, Distribution process and procedure * Experience in managing large implementations/upgrade project * Strong ...
Princeton, NJ ยท On-site
GAMP 5 Risk-Based validation / ICH Q9 hands-on implementation knowledge * Manufacturing, Distribution process and procedure * Experience in managing large implementations/upgrade project * Strong ...
GAMP 5 Risk-Based validation / ICH Q9 hands-on implementation knowledge * Manufacturing, Distribution process and procedure * Experience in managing large implementations/upgrade project * Strong ...
GAMP 5 Risk-Based validation / ICH Q9 hands-on implementation knowledge * Manufacturing, Distribution process and procedure * Experience in managing large implementations/upgrade project * Strong ...
Cranbury, NJ ยท On-site
$73K - $117K/yr
Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements and good documentation practices. * Experience in the qualification of biologics ...
Cranbury, NJ ยท On-site
$73K - $117K/yr
Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements and good documentation practices. * Experience in the qualification of biologics ...
This role serves as a liaison across Quality, IT, Laboratory, and Manufacturing functions, ensuring systems are validated and maintained in compliance with 21 CFR Part 11, GxP, and EMA requirements.
This role serves as a liaison across Quality, IT, Laboratory, and Manufacturing functions, ensuring systems are validated and maintained in compliance with 21 CFR Part 11, GxP, and EMA requirements.
This role serves as a liaison across Quality, IT, Laboratory, and Manufacturing functions, ensuring systems are validated and maintained in compliance with 21 CFR Part 11, GxP, and EMA requirements.
This role serves as a liaison across Quality, IT, Laboratory, and Manufacturing functions, ensuring systems are validated and maintained in compliance with 21 CFR Part 11, GxP, and EMA requirements.
Familiarity with Pharmaceutical Development IT. * Experience with Computer Systems Validation, working knowledge of 21 CFR Part 11. * Experience with LIMS systems. * Experience with MODA is a plus.
Familiarity with Pharmaceutical Development IT. * Experience with Computer Systems Validation, working knowledge of 21 CFR Part 11. * Experience with LIMS systems. * Experience with MODA is a plus.
Piscataway, NJ ยท On-site
$70K - $90K/yr
Working knowledge of Computer Systems Validation lifecycle and documentation. * Proficient in Microsoft Word, Excel, and PowerPoint. * Must be able to work independently with adequate supervision ...
Piscataway, NJ ยท On-site
$70K - $90K/yr
Working knowledge of Computer Systems Validation lifecycle and documentation. * Proficient in Microsoft Word, Excel, and PowerPoint. * Must be able to work independently with adequate supervision ...
$70K - $90K/yr
Working knowledge of Computer Systems Validation lifecycle and documentation. * Proficient in Microsoft Word, Excel, and PowerPoint. * Must be able to work independently with adequate supervision ...
$70K - $90K/yr
Working knowledge of Computer Systems Validation lifecycle and documentation. * Proficient in Microsoft Word, Excel, and PowerPoint. * Must be able to work independently with adequate supervision ...
... systems, LLM-based applications, AI agents, orchestration frameworks, prompt/model lifecycle ... of Computer System Validation (CSV) experience in GxP-regulated environments, with hands-on ...
... systems, LLM-based applications, AI agents, orchestration frameworks, prompt/model lifecycle ... of Computer System Validation (CSV) experience in GxP-regulated environments, with hands-on ...
Raritan, NJ ยท On-site
$48 - $53/hr
Experience in the Pharmaceutical, biotechnology, or medical device industry. * 2+ years' experience with System Development Lifecycle. * 3+ years' experience in Computer System Validation.
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Raritan, NJ ยท On-site
$48 - $53/hr
Experience in the Pharmaceutical, biotechnology, or medical device industry. * 2+ years' experience with System Development Lifecycle. * 3+ years' experience in Computer System Validation.
Rahway, NJ ยท On-site
$180 - $230/hr
... systems (QMS) * Oversee validation risk management, ensuring balanced, risk-based approaches to ... Bachelor's Degree in computer science, math or science with a minimum of 10 year's experience ...
Rahway, NJ ยท On-site
$180 - $230/hr
... systems (QMS) * Oversee validation risk management, ensuring balanced, risk-based approaches to ... Bachelor's Degree in computer science, math or science with a minimum of 10 year's experience ...
Raritan, NJ ยท On-site
Role - Validation Lead Location - Raritan, NJ (Hybrid) W2/C2C Job Details: 5+ years of Computer System Validation (CSV) experience in GxP-regulated environments, with hands-on experience in retro ...
Raritan, NJ ยท On-site
Role - Validation Lead Location - Raritan, NJ (Hybrid) W2/C2C Job Details: 5+ years of Computer System Validation (CSV) experience in GxP-regulated environments, with hands-on experience in retro ...
This role will leverage knowledge of Waters Empower, Waters NuGenesis, Agilent OpenLab, and various bench-top instruments, together with GAMP 5, 21 CFR Part 11, and Computer System Validation ...
New
This role will leverage knowledge of Waters Empower, Waters NuGenesis, Agilent OpenLab, and various bench-top instruments, together with GAMP 5, 21 CFR Part 11, and Computer System Validation ...
New
This role will leverage knowledge of Waters Empower, Waters NuGenesis, Agilent OpenLab, and various bench-top instruments, together with GAMP 5, 21 CFR Part 11, and Computer System Validation ...
New
This role will leverage knowledge of Waters Empower, Waters NuGenesis, Agilent OpenLab, and various bench-top instruments, together with GAMP 5, 21 CFR Part 11, and Computer System Validation ...
New
New York, NY ยท On-site +1
Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...
New York, NY ยท On-site +1
Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...
Participate in laboratory computer system validation activities associated with new or upgraded instrumentation or software packages in compliance with 21CFR11 compliance requirements.Prepare, review ...
New
Participate in laboratory computer system validation activities associated with new or upgraded instrumentation or software packages in compliance with 21CFR11 compliance requirements.Prepare, review ...
New
New York, NY ยท On-site +1
Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...
New York, NY ยท On-site +1
Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...
Morristown, NJ ยท On-site +1
Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...
Morristown, NJ ยท On-site +1
Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...
Morristown, NJ ยท On-site +1
Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...
Morristown, NJ ยท On-site +1
Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...
$10.81 - $17.83
2% of jobs
$17.83 - $24.84
9% of jobs
$24.84 - $31.86
1% of jobs
$31.86 - $38.87
4% of jobs
$43.13 is the 25th percentile. Wages below this are outliers.
$38.87 - $45.88
15% of jobs
$45.88 - $52.90
9% of jobs
The median wage is $58.74 / hr.
$52.90 - $59.91
13% of jobs
$65.50 is the 75th percentile. Wages above this are outliers.
$59.91 - $66.93
29% of jobs
$66.93 - $73.94
12% of jobs
$73.94 - $80.96
2% of jobs
$80.96 - $87.97
5% of jobs
$10
$55
$87
| Aspect | Computer Systems Validation | Quality Assurance Specialist |
|---|---|---|
| Certifications | GAMP, CSV-specific training | ISO 9001, Six Sigma |
| Work Environment | Regulated industries like pharma, biotech | Manufacturing, software, service sectors |
| Primary Focus | Ensuring computer systems meet regulatory standards | Ensuring overall product/service quality |
| Common Usage | Validation of software, hardware in compliance | Process audits, quality improvement |
Computer Systems Validation and Quality Assurance Specialist roles overlap in ensuring compliance and quality. However, CSV focuses specifically on validating computer systems to meet regulatory standards, especially in pharma and biotech industries. Quality Assurance Specialists have a broader scope, overseeing overall quality processes across various sectors. Both roles require similar certifications and work environments but differ in their primary objectives and specific tasks.
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