Hovione · 4 days ago
Quality Assurance Specialist
East Windsor, NJ
Full-time
Onsite
Mid Level
$92K/yr - $147K/yr
3+ years expHovione is an independent family-owned international group dedicated to helping pharmaceutical customers bring new and off-patent drugs to market. The Quality Assurance Specialist will manage quality activities for assigned projects in compliance with cGMP standards, promote high-quality levels, and ensure continuous improvement in quality processes.
Pharmaceutical
Hiring Manager
Kate Puccio
Responsibilities
Rigorously, accurately, efficiently and professionally manage all quality activities for the assigned projects and / or products in accordance with applicable cGMP, quality operational standards / procedures and legal regulations, ensuring the site is always 'audit ready'
Promote the importance of high-quality levels and the importance of a continuous improvement culture in relevant company activities
Act as a catalyst for change and improvement in performance/quality
Assigned projects may relate to any of the following (non-exhaustive) areas: Raw Materials, Suppliers, Specifications, Production Processes, Change Control, Deviations, Quality agreements, Qualification and Validation, Stability Programs, Batch Release, Equipment Cleaning, Client Audits, Internal Audits, Customer Complaints, Customer requirements, PQR
Provide an example of professionalism and support the induction and training of new colleagues within the area
Efficiently, accurately and reliably ensure that project and / or product activities are delivered in compliance with cGMP requirements and maintenance of the company Quality Management System is assured
Qualification
Required
University, or equivalent, qualification in Chemistry, Chemical Engineering, Pharmaceutical Sciences or similar scientific field (mandatory)
Experience of working in a GMP operational environment (mandatory)
Training and experience of GMP standards (mandatory)
Strong understanding and knowledge of GMP practices
Fluency in English is a requirement
Computer literate with good working knowledge of the MS Office package
Strong documentation skills and attention to detail
Preferred
Typically requires 3-5 years of relevant experience in a QA GMP environment within the Pharmaceutical Industry (highly desirable)
Experience of working with Regulatory Affairs and a basic knowledge of the function (desirable)
Benefits
401(k)
Paid time off
Leaves
Health coverage (medical, dental, vision)
Company
Hovione
Hovione is a Pharmaceutical Company.
1001-5000 employees
H1B Sponsorship
Hovione 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 (8)
2024 (7)
2023 (5)
2022 (5)
2021 (2)
2020 (3)
Funding
Current Stage
Late StageTotal Funding
unknown2024-01-01Private Equity
Leadership Team
Angie (Agnieszka) Baczyk, MBA, SHRM-CP
Senior Human Resources Business Partner
Kristen Parisi
Human Resources Business Partner
Recent News
Essential Business
2026-02-03
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