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Aequor

Specialist QA - Validation, cGMP

Woburn, MA

Company Description Engineering Job Title- Specialist QA Location- Woburn, MA Duration - 12 months with possible extension Key Skills - QA Pharma, Bio, biopharma, cGMP, validation, conformance, CAPAs ...

Integrated Resources INC

Quality Assurance

Andover, MA · On-site

The scope of work for this role is to provide QA Validation support to validation activities associated with Quality Control (QC) Laboratory instruments. The main responsibility is review and ...

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How much do qa validation jobs pay per hour?

As of Jun 8, 2026, the average hourly pay for qa validation in the United States is $56.31, according to ZipRecruiter salary data. Most workers in this role earn between $41.59 and $70.43 per hour, depending on experience, location, and employer.

What are some common challenges faced by QA Validation professionals in regulated industries?

QA Validation professionals in regulated industries often face the challenge of staying current with evolving compliance standards while ensuring that all processes and documentation meet strict regulatory requirements. They must balance thorough validation activities with tight project timelines, often collaborating closely with cross-functional teams such as manufacturing, engineering, and regulatory affairs. Attention to detail and strong organizational skills are essential, as even small errors can lead to costly delays or regulatory findings. Effective communication with team members and stakeholders is also critical to ensure successful audits and product launches.

What are QA Validation professionals?

QA Validation professionals are specialists responsible for ensuring that products, processes, or systems meet defined quality standards and regulatory requirements. They design and execute tests, document results, and analyze data to confirm that all specifications are met before a product is released or a process goes live. Their work is crucial in industries such as pharmaceuticals, manufacturing, and software, where compliance and consistent quality are essential. QA Validation experts help prevent defects, ensure safety, and maintain customer trust.

What is the difference between Qa Validation vs Qa Analyst?

AspectQa ValidationQa Analyst
CertificationsGMP, GxP, Validation certificationsGMP, GxP, Quality assurance certifications
Work EnvironmentRegulated industries like pharma, biotechPharmaceutical, biotech, manufacturing
Primary FocusValidating processes, systems, equipmentAnalyzing quality data, audits, process improvements
Employer UsageQuality validation teams in regulated industriesQuality assurance departments across industries

Qa Validation specialists focus on validating systems and processes to ensure compliance with industry standards, often working on equipment and software validation. Qa Analysts primarily analyze quality data, perform audits, and support process improvements. While both roles ensure product quality, Qa Validation emphasizes validation activities, whereas Qa Analysts focus on ongoing quality analysis and reporting.

What are the key skills and qualifications needed to thrive as a QA Validation professional, and why are they important?

To thrive as a QA Validation professional, you need a solid understanding of quality assurance processes, regulatory standards (such as FDA or ISO), and a relevant science or engineering degree. Familiarity with validation protocols, documentation systems, and tools like LIMS or TrackWise is typically required, along with certifications such as ASQ CQV or similar. Attention to detail, analytical thinking, and effective communication are essential soft skills for ensuring compliance and facilitating teamwork. These competencies are critical for guaranteeing product quality, regulatory compliance, and the smooth operation of validation activities in highly regulated industries.
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Qa Validation jobs near you
Infographic showing various Qa Validation job openings in the United States as of May 2026, with employment types broken down into 1% As Needed, 91% Full Time, 4% Part Time, and 4% Contract. Highlights an 89% Physical, 3% Hybrid, and 8% Remote job distribution, with an average salary of $117,123 per year, or $56.3 per hour.
QA & Validation Lead (Life Sciences Platforms)

QA & Validation Lead (Life Sciences Platforms)

Inficare Technologies

Remote

Full-time

Posted 2 days ago

Job description

QA & Validation Lead (Life Sciences Platforms)
Location : Remote (EST time)
Duration: Long term
Position Summary
We are seeking an experienced QA Lead / Test Lead to drive quality assurance and validation activities across critical systems in a regulated life sciences environment. This role will lead testing strategy, execution, and compliance for GxP systems such as CRM, MLR platforms, data platforms, and enterprise applications. The ideal candidate brings deep expertise in validation, strong leadership capabilities, and a thorough understanding of regulatory requirements (FDA, GxP, 21 CFR Part 11).
Key Responsibilities
QA Leadership & Strategy
  • Define and lead QA and testing strategy across projects and platforms
  • Establish testing standards, methodologies, and best practices
  • Manage end-to-end testing lifecycle (SIT, UAT, regression, validation testing)
  • Act as the primary QA point of contact for stakeholders and leadership

Validation & Compliance (CSV)
  • Lead Computer System Validation (CSV) activities in alignment with GxP requirements
  • Author and review validation deliverables (e.g., Validation Plan, URS, FS/DS, IQ/OQ/PQ, Traceability Matrix)
  • Ensure systems comply with FDA regulations, 21 CFR Part 11, and data integrity standards (ALCOA+)
  • Support audit readiness and participate in internal/external audits

Test Management & Execution
  • Develop detailed test plans, test cases, and test scripts
  • Oversee defect management lifecycle, including tracking, triage, and resolution
  • Coordinate SIT/UAT cycles with business stakeholders and SMEs
  • Ensure appropriate test coverage, risk-based testing, and documentation

Team Leadership & Collaboration
  • Lead and mentor QA analysts and offshore/onshore testing teams
  • Collaborate with Business Analysts, Product Owners, IT, and vendors
  • Provide status reporting, risk assessment, and executive-level updates
  • Drive continuous improvement across QA processes and tools

Supported Systems & Platforms
  • CRM: Veeva CRM, Salesforce
  • MLR/PRC: Veeva PromoMats, AgileLoft
  • Data & Analytics: Snowflake, Databricks, Power BI
  • LMS: ComplianceWire or similar
  • Clinical / Regulatory / Quality systems as applicable

Required Qualifications
  • Bachelor's degree in Life Sciences, Computer Science, or related field
  • 7+ years of QA/testing experience, including 2-3+ years in a lead role
  • Strong experience with Computer System Validation (CSV) in GxP environments
  • Deep knowledge of FDA regulations, 21 CFR Part 11, and data integrity principles
  • Proven experience in test management tools (e.g., Jira, ALM, Azure DevOps)
  • Experience leading cross-functional and distributed QA teams
  • Strong understanding of SDLC methodologies (Waterfall, Agile, Hybrid)

Preferred Qualifications
  • Experience with Veeva Vault, AgileLoft, or other life sciences platforms
  • Familiarity with automation testing tools (e.g., Selenium, Test automation frameworks)
  • Experience with cloud platforms (AWS, Azure) and data validation
  • Knowledge of risk-based validation approaches (CSA - Computer Software Assurance)
  • PMP, ISTQB, or related QA/validation certifications

Key Competencies
  • Regulatory and compliance expertise
  • Leadership and team management
  • Strong analytical and problem-solving skills
  • Attention to detail and documentation rigor
  • Excellent stakeholder communication and influencing skills

Apply