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Dexian · 2 days ago

Quality Assurance Specialist (Pharmaceuticals)

Norton, MA

Contract

Onsite

Entry, Mid Level

$44/hr - $48/hr

2+ years exp

Dexian is a leading provider of staffing, IT, and workforce solutions. The QA Associate will help ensure that life-changing biopharmaceutical products are manufactured to the highest standards by providing day-to-day QA support across various operations at the Norton site, partnering with cross-functional teams to maintain GMP compliance and inspection readiness.

ConsultingHuman ResourcesInformation TechnologyProfessional ServicesStaffing Agency

H1B Sponsor Likely

Hiring Manager

Prathamesh Waghmode

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 regulations knowledgeBachelor’s degree in scienceQuality systems experienceAttention 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

Dexian

Glassdoor3.5

Dexian provides services for staffing, talent development, and consulting, with a focus on technology, finance, and project management.

Founded in 1994

Mclean, Virginia, USA

1001-5000 employees

https://dexian.com

H1B Sponsorship

Dexian 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 (65)