Eugia US LLC
Division Overview
Eugia is a U.S.-based independent specialty pharmaceutical company focused on generic sterile injectables, oncology, hormones, and ophthalmic medicines. Eugia has best‑in‑class manufacturing and R&D capabilities to meet customer needs as they arise and is committed to providing high‑quality specialty medicines.
Eugia’s mission is to make the purchase of specialty pharmaceutical products an experience customers look forward to. Our vision is to become synonymous with excellent customer service and to continuously improve by being transparent, responsive, and consistent. We are expanding our capabilities to include the manufacture of highly complex injectables.
Eugia is the partner of choice for delivering the promise of generic specialty pharmaceuticals.
Job Overview Under the oversight of the Associate Manager of QA Compliance, the Quality Compliance Associate will establish an internal QA review system to supervise the PVG function, which is handled by third parties. The role also involves creating a QA system to notify the FDA of illegitimate products as needed. The Associate will review all Eugia finished‑product batches for compliance with applicable regulatory and cGMP requirements prior to release for commercial distribution. Maintenance and improvement of the Eugia quality systems needed to support GMP activities will also be required.
The position is based in East Windsor, New Jersey and is not eligible for relocation or sponsorship. This is a short‑term (6‑month) hourly role, with a possibility of conversion to full‑time permanent status that is not guaranteed.
Responsibilities
Prepare, review, and finalize SOPs, MAPPs, internal guidelines, and review checklists to supervise the PVG function of Eugia’s products.
Coordinate with the third‑party PVG team to establish the standard review process of PVG reports generated for Eugia’s products.
Prepare, review, and finalize SOPs, MAPPs, and internal guidelines for creating a QA system to notify the FDA of illegitimate products.
Coordinate and communicate with cross‑functional teams (CFTs) to gather the required data and information to notify the FDA of illegitimate products.
Assist the Associate Manager of QA Compliance in notifying the FDA of illegitimate products within the FDA’s pre‑defined timeline.
Conduct social media monitoring for any product quality or safety related complaints for Eugia’s products and inform the third‑party PVG team for further processing as needed.
Compile and archive batch‑related documents, keeping all GMP records in compliance with Good Documentation Practices.
Provide periodic updates to the immediate manager on quality‑related concerns.
This is not an exhaustive list of all responsibilities, duties, skills, efforts, or requirements associated with the role. Management reserves the right to revise the job or require other tasks to be performed with or without notice.
Qualifications – Skills & Requirements
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.
Education & Experience
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 or medical devices.
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.
Previous experience in quality assurance/compliance is preferred.
Physical Requirements
Stand, sit; talk, hear, and use hands and fingers to operate a computer and telephone keyboard; reach, stoop, kneel to install computer equipment.
Specific vision abilities required: close vision due to computer work.
Light to moderate lifting required.
Moderate noise (business office with computers, phone, and printers, light traffic).
Ability to sit at a computer terminal for an extended period; sedentary work may involve lifting up to 10 pounds occasionally.
Additional Physical Requirements No additional requirements.
Blood / Fluid Exposure Risk Category III: Tasks involve no exposure to blood, body fluids, or tissues. Category I tasks are not a condition of employment.
Seniority Level
Entry level
Employment Type
Full‑time
Job Function
Finance and Sales
Pharmaceutical Manufacturing
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Eugia’s mission is to make the purchase of specialty pharmaceutical products an experience customers look forward to. Our vision is to become synonymous with excellent customer service and to continuously improve by being transparent, responsive, and consistent. We are expanding our capabilities to include the manufacture of highly complex injectables.
Eugia is the partner of choice for delivering the promise of generic specialty pharmaceuticals.
Job Overview Under the oversight of the Associate Manager of QA Compliance, the Quality Compliance Associate will establish an internal QA review system to supervise the PVG function, which is handled by third parties. The role also involves creating a QA system to notify the FDA of illegitimate products as needed. The Associate will review all Eugia finished‑product batches for compliance with applicable regulatory and cGMP requirements prior to release for commercial distribution. Maintenance and improvement of the Eugia quality systems needed to support GMP activities will also be required.
The position is based in East Windsor, New Jersey and is not eligible for relocation or sponsorship. This is a short‑term (6‑month) hourly role, with a possibility of conversion to full‑time permanent status that is not guaranteed.
Responsibilities
Prepare, review, and finalize SOPs, MAPPs, internal guidelines, and review checklists to supervise the PVG function of Eugia’s products.
Coordinate with the third‑party PVG team to establish the standard review process of PVG reports generated for Eugia’s products.
Prepare, review, and finalize SOPs, MAPPs, and internal guidelines for creating a QA system to notify the FDA of illegitimate products.
Coordinate and communicate with cross‑functional teams (CFTs) to gather the required data and information to notify the FDA of illegitimate products.
Assist the Associate Manager of QA Compliance in notifying the FDA of illegitimate products within the FDA’s pre‑defined timeline.
Conduct social media monitoring for any product quality or safety related complaints for Eugia’s products and inform the third‑party PVG team for further processing as needed.
Compile and archive batch‑related documents, keeping all GMP records in compliance with Good Documentation Practices.
Provide periodic updates to the immediate manager on quality‑related concerns.
This is not an exhaustive list of all responsibilities, duties, skills, efforts, or requirements associated with the role. Management reserves the right to revise the job or require other tasks to be performed with or without notice.
Qualifications – Skills & Requirements
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.
Education & Experience
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 or medical devices.
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.
Previous experience in quality assurance/compliance is preferred.
Physical Requirements
Stand, sit; talk, hear, and use hands and fingers to operate a computer and telephone keyboard; reach, stoop, kneel to install computer equipment.
Specific vision abilities required: close vision due to computer work.
Light to moderate lifting required.
Moderate noise (business office with computers, phone, and printers, light traffic).
Ability to sit at a computer terminal for an extended period; sedentary work may involve lifting up to 10 pounds occasionally.
Additional Physical Requirements No additional requirements.
Blood / Fluid Exposure Risk Category III: Tasks involve no exposure to blood, body fluids, or tissues. Category I tasks are not a condition of employment.
Seniority Level
Entry level
Employment Type
Full‑time
Job Function
Finance and Sales
Pharmaceutical Manufacturing
#J-18808-Ljbffr