What are the responsibilities and job description for the Quality Compliance Associate position at Eugia US LLC?
Division Overview:
Eugia’s mission is to make the process of buying specialty pharmaceutical products an experience customers look forward to, and our vision is to become synonymous with excellent customer service and continuously improve upon this excellence by being transparent, responsive, and consistent. We are expanding Eugia’s capabilities to include the manufacture of highly complex injectables to answer that need.
Eugia is the partner of choice to deliver on the promise of generic specialty pharmaceuticals.
Job Overview:
The Quality Compliance Associate position is based in East Windsor New Jersey and not eligible for relocation or sponsorship.
This is not an exhaustive list of all responsibilities, duties, skills, efforts, or requirements associated with the role. While this is intended to be an accurate reflection of the current job, management reserves the right to revise the job or to require that other or different tasks be performed as assigned with or without notice.
Qualifications - Skills & Requirements:
The hourly pay rate for this position may go up to $34.00 per hour, depending on factors such as experience level, knowledge, skills, and abilities. Final compensation decisions will consider these and other relevant business needs. 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.
Physical Requirements: OFFICE POSITION - While performing the duties of this job the employee is required to: •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 by this job include close vision requirements due to computer work •Light to moderate lifting is required •Moderate noise (i.e. business office with computers, phone, and printers, light traffic). •Ability to sit at a computer terminal for an extended period of time Sedentary work Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met. 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.
Eugia is US-based independent specialty pharmaceutical company focused on generic sterile injectables, oncology, hormones, and ophthalmic medicines. Eugia has best-in-class, dedicated manufacturing and R&D capabilities to meet customer needs as they emerge. We are committed to consistently providing our customers with high quality specialty medicines.
Eugia’s mission is to make the process of buying specialty pharmaceutical products an experience customers look forward to, and our vision is to become synonymous with excellent customer service and continuously improve upon this excellence by being transparent, responsive, and consistent. We are expanding Eugia’s capabilities to include the manufacture of highly complex injectables to answer that need.
Eugia is the partner of choice to deliver on the promise of generic specialty pharmaceuticals.
Under the oversight of the Associate Manager of QA Compliance, the Quality Compliance Associate will be responsible for establishing the internal QA review system to supervise the PVG function, handled by third party. Also, responsible for creating a QA system to notify FDA of Illegitimate Products, as and when needed. This position will also be reviewing all Eugia finished product batches for compliance with applicable regulatory and cGMP requirements prior to release for commercial distribution, as needed. Maintenance and/ or improvement of the Eugia quality systems necessary to support GMP related activities will also be required.
The Quality Compliance Associate position is based in East Windsor New Jersey and not eligible for relocation or sponsorship.
This is a short‑term (6 months) hourly role. While there is a possibility of conversion to full‑time permanent status, this outcome is not guaranteed.
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.
This is not an exhaustive list of all responsibilities, duties, skills, efforts, or requirements associated with the role. While this is intended to be an accurate reflection of the current job, management reserves the right to revise the job or to require that other or different tasks be performed as assigned with or without notice.
- 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 Pharmaceutica/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.
The hourly pay rate for this position may go up to $34.00 per hour, depending on factors such as experience level, knowledge, skills, and abilities. Final compensation decisions will consider these and other relevant business needs. 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.
Salary : $34