Quality Assurance Specialist - GMP jobs in United States
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Collabera · 21 hours ago

Quality Assurance Specialist - GMP

Collabera is a company in the pharmaceutical industry, and they are seeking a Quality Assurance Specialist to support global quality risk management initiatives. The role involves leading cross-functional projects, executing risk assessments, and driving quality risk deliverables across global teams.

ConsultingInformation ServicesInformation Technology
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H1B Sponsor Likelynote
Hiring Manager
Deepak Arya
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Responsibilities

Lead and facilitate quality risk management project meetings with global stakeholders
Develop and execute regulatory aligned risk assessments and governance documentation
Track project milestones deliverables and timelines to ensure on time execution
Perform quality review of risk management and governance documentation
Collaborate with quality manufacturing supply chain and scientific teams
Develop metrics dashboards and visualizations for executive level reporting
Maintain records supporting quality system initiatives and compliance
Support global quality system improvements and strategic transformation initiatives

Qualification

Quality AssuranceQuality Risk ManagementRegulatory ComplianceGMP KnowledgeDocument ControlChange ManagementElectronic Quality Management SystemsMetrics DashboardsScientific DegreeProject ManagementExcelPowerPointVisioPowerBIWordTeamsSharePointDigital Quality ToolsCross Functional ExperienceExecutive CommunicationIndependent Work

Required

Minimum 5 years of experience in quality assurance quality systems or quality risk management
Hands on experience with regulatory compliance and quality risk governance
Proven project management experience supporting global or cross functional initiatives
Strong knowledge of GMP and global regulatory guidelines including ICH US and EU
Experience performing risk assessments governance frameworks and mitigation planning
Experience with document control and change management processes
Working knowledge of electronic quality management systems
Intermediate to advanced proficiency with Enterprise tools including Excel, PowerPoint, Visio, PowerBI, Word, Teams and SharePoint
Experience developing metrics dashboards and executive reporting
Ability to work independently while managing multiple priorities
Bachelors degree in a scientific or technical discipline such as biology chemistry engineering or pharmacy

Preferred

Experience developing digital or automated quality tools
Previous experience working in global cross functional environments
Strong PowerBI dashboard development experience
Advanced executive level presentation and communication skills

Benefits

Medical insurance
Dental insurance
Vision insurance
401(k) retirement plan
Life insurance
Long-term disability insurance
Short-term disability insurance
Paid parking/public transportation
Paid time
Paid sick and safe time
Hours of paid vacation time
Weeks of paid parental leave
Paid holidays annually - AS Applicable

Company

Collabera

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Collabera is an end-to-end information technology services and solutions provider helping clients align their business and IT strategies.

H1B Sponsorship

Collabera has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (141)
2024 (93)
2023 (120)
2022 (186)
2021 (180)
2020 (146)

Funding

Current Stage
Late Stage
Total Funding
$30M
2006-05-04Series Unknown· $30M

Leadership Team

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Lalit Sharma
CFO
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Michael H. Abraham
Chief Financial Officer
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Company data provided by crunchbase