Eugia US LLC · 1 day ago
Quality Compliance Associate
East Windsor, NJ
Full-time
Onsite
Entry Level
1+ years expEugia US LLC is an independent specialty pharmaceutical company focused on generic sterile injectables and oncology products. The Quality Compliance Associate will establish internal QA review systems, supervise the PVG function, and ensure compliance with regulatory requirements for finished product batches before commercial distribution.
ManufacturingPharmaceutical
No H1B
Responsibilities
Prepare, Review and Finalize the SOPs, MAPPs, Internal Guidelines, Review Checklist to supervise the PVG function of Eugia’s products
Coordinate with Third-party PVG team to establish the standard review process of PVG Reports, generated for Eugia’s products
Prepare, Review and Finalize the SOPs, MAPPs, Internal Guidelines for creating a QA system to notify FDA of Illegitimate Products, as and when needed
Coordinate & Communicate with Cross-functional team (CFTs) to gather the required data/information to notify FDA of Illegitimate Products
Assist Associate Manager of QA Compliance to notify FDA of Illegitimate Products within FDA’s pre-defined timeline
As and when needed, conduct Social Media Monitoring for any product quality/safety related complaints for Eugia’s product and inform the third part PVG team for further processing
Compile and archive the batch related documents. Keep all GMP records in compliance with Good Documentation Practices
Provide periodic updates to immediate manager on Quality related concerns
Qualification
Required
Effective communication and interpersonal skills, with the ability to work collaboratively in cross-functional teams
Strong computer skills, including proficiency in Microsoft Office Suite
Commitment to maintaining a high level of integrity and professionalism
Bachelor's degree in a scientific or related field
Previous experience in quality assurance or quality compliance role, preferably in a regulated industry such as pharmaceuticals, medical devices etc
Brief Knowledge of PVG, Form 3911, SOPs, Change Control Processes, CFR & GMP Regulations
1-2 years' experience in the Pharmaceutical/Biotech industry with knowledge of cGMP regulations as they pertain to API and sterile finished drug products
Preferred
Previous experience in Quality Assurance/Compliance is preferred
Benefits
In addition to base salary, this position is eligible for an annual bonus, with target percentages varying by role.
The total compensation package may also include discretionary incentives and role-based monthly allowances (e.g., cell phone or car allowance, where applicable).
As a temporary role upon hire, this position is not eligible for company sponsored Health and Welfare benefits.
Company
Eugia US LLC
Eugia is an independent specialty pharmaceutical company focused on delivering generic sterile injectables, oncology, hormones, and ophthalmic medicines.
201-500 employees
Funding
Current Stage
Growth StageRecent News
2025-06-29
Company data provided by crunchbase