QA Associate - Quality Operations jobs in United States
cer-icon
Apply on Employer Site
company-logo

Integrated Resources, Inc ( IRI ) · 1 day ago

QA Associate - Quality Operations

Integrated Resources, Inc (IRI) is a company focused on biopharmaceutical products, and they are seeking a QA Associate to ensure that these products are manufactured to the highest standards. The role involves providing QA support across various functions to maintain GMP compliance and inspection readiness.

BiotechnologyHealth CareHuman ResourcesRecruitingStaffing Agency
check
H1B Sponsor Likelynote

Responsibilities

Provide raw material support, including review/approval of incoming material documentation and release for GMP use
Deliver on-the-floor QA support to manufacturing, including area clearance and changeover operations, ensuring readiness for production activities
Review and approve SOPs, master batch records (MBRs), specifications, risk assessments, and quality documents
Generate and maintain Quality-related SOPs and controlled forms
Review and approve validation documents and protocol executions to confirm compliance with approved procedures and regulatory requirements
Review and approve QC laboratory qualification documents, including equipment qualification
Perform executed batch record review and approval to ensure accuracy and compliance
Review and approve deviations, CAPAs, Change Controls and related investigations in the quality management system
Support partner audits and regulatory inspections, including document retrieval and subject matter input
Approve work orders in the maintenance system to verify equipment maintenance and calibration compliance
Collaborate with internal cross-functional teams at the Norton facility to drive continuous improvement and quality excellence

Qualification

GMP experienceCGMP regulationsQuality systemsBachelor’s degreeAttention to detailOrganizational skillsEffective communication

Required

Bachelor's degree in a scientific or engineering discipline (Biology, Chemistry, Biotechnology, etc.) or equivalent experience
2–4 years of GMP experience in Quality, Manufacturing, or QC
Knowledge of cGMP regulations (21 CFR Parts 210/211/11, ICH Q7/Q10) and Good Documentation Practices
Strong attention to detail, organizational skills, and the ability to communicate effectively across teams

Preferred

Experience with quality systems (e.g., Veeva, SAP) is a plus

Company

Integrated Resources, Inc ( IRI )

company-logo
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