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Quality Compliance Associate

System One • East Windsor, NJ • 2h ago

Job Title: Quality Compliance Associate

Location: East Windsor, New Jersey

Type: Contract

Compensation: $26 - $36 per hour

Contractor Work Model: Onsite

Hours: 8/9 AM - 5/6 PM, Monday to Friday

Industry: Pharmaceuticals, Sterile Injectable Products

Responsibilities:

Under the oversight of the Associate Manager of Quality Assurance (QA) Compliance, this position will be responsible for establishing the internal QA review system to supervise the Pharmacovigilance Group (PVG) function, which is handled by a third-party vendor.

Additionally, the position is responsible for creating a QA system to notify the U.S. Food and Drug Administration (FDA) of illegitimate products, as and when needed.

This position will also review all finished product batches for compliance with applicable regulatory requirements and current Good Manufacturing Practice (cGMP) standards prior to release for commercial distribution, as needed.

Maintenance and/or improvement of the company's quality systems necessary to support GMP-related activities will also be required.

Prepare, review, and finalize Standard Operating Procedures (SOPs), Master Approval Process Procedures (MAPPs), internal guidelines, and review checklists to supervise the Pharmacovigilance Group (PVG) function of company products.

Coordinate with third-party PVG team to establish the standard review process of PVG reports generated for company products.

Prepare, review, and finalize SOPs, MAPPs, and internal guidelines for creating a QA system to notify the FDA of illegitimate products, as and when needed.

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.

As needed, conduct social media monitoring for any product quality or safety-related complaints and inform the third-party PVG team for further processing.

Compile and archive batch-related documents. Keep all GMP records in compliance with Good Documentation Practices (GDP).

Provide periodic updates to the immediate manager on quality-related concerns.

Requirements:

Bachelor's degree in a scientific or related field.

Previous experience in a quality assurance or quality compliance role, preferably in a regulated industry such as pharmaceuticals, medical devices, or biotechnology.

Basic knowledge of Pharmacovigilance Group (PVG) processes, FDA Form 3911, SOPs, change control processes, Code of Federal Regulations (CFR), and Good Manufacturing Practice (GMP) regulations.

1-2 years of experience in the pharmaceutical or biotechnology industry, with knowledge of cGMP regulations as they pertain to active pharmaceutical ingredients (API) and sterile finished drug products. Previous experience in Quality Assurance/Compliance is preferred.

Strong computer skills, including proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).

System One, and its subsidiaries including Joulé, ALTA IT Services, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

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Ref: #558-Scientific

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

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