Field Specialist QA Operations jobs in United States
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Integrated Resources, Inc ( IRI ) · 19 hours ago

Field Specialist QA Operations

Integrated Resources, Inc (IRI) is seeking a Contractor Field QA Specialist for the QA Operations organization at the LSCC in Devens, MA. The role involves overseeing quality activities in accordance with client policies and global cGMP standards, ensuring compliance with manufacturing procedures and batch records.

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H1B Sponsor Likelynote

Responsibilities

Perform QA on the floor activities
Ensure manufacturing compliance with applicable procedures and batch records
Perform real-time review of manufacturing batch records
Review manufacturing shop floor documentation

Qualification

FDA regulated cGMP knowledgeQuality Assurance experienceQuality Risk ManagementGMP Manufacturing knowledgeContinuous improvementAnalytical thinkingDecision-makingProblem solvingConflict managementCommunication skills

Required

Relevant college or university Associate's or Bachelor's degree required
Minimum 4 years relevant work experience, with experience in a Quality Assurance role
Equivalent combination of education and experience might be acceptable
Must be action-oriented and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking
Understands continuous improvement and improves efficiency and productivity within the group or project
Builds relationships internally within and with cross-functional teams
Must have sound knowledge and experience in FDA regulated cGMP warehousing, Quality, and compliance environments
Prefer knowledge of GMP Manufacturing operations and processes
Directs quality initiatives that accomplish continuous improvement and enhance site quality system efficiencies
Routinely recognizes and resolves Quality issues; informs management of proposed solutions and seeks guidance on complex issues
Able to recognize conflict and notify management with proposed recommendations for resolution
Must possess an independent mindset; work is self-directed
Requires moderate direction to complete more complex tasks; completes routine tasks with little or no supervision
Confident in making decisions for non-routine issues
Develops and revises procedures
Intermediate to advanced ability to interpret results and situations and articulate recommendations for resolution
Able to prepare written communications and communicate problems to management with clarity and accuracy
Able to effectively multi-task
Knowledge of US and global cGMP requirements
Must have strong authorship and ability to critically review investigations, interpret results, and generate technical conclusions consistent with Quality Risk Management principles
Knowledge of quality processes, including material disposition, change control, product complaints, deviations, investigations, and CAPA management

Company

Integrated Resources, Inc ( IRI )

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Integrated Resources Inc.

H1B Sponsorship

Integrated Resources, Inc ( IRI ) 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 (7)
2024 (5)
2023 (13)
2022 (9)
2021 (25)
2020 (39)

Funding

Current Stage
Late Stage
Company data provided by crunchbase