Quality Associate II

Quality Associate II
12-month Contract
Prefer Hybrid in Princeton, NJ – open to remote

Requirements:

Ensures GMP compliance for outsourced clinical manufacturing, packaging, labeling, and testing activities.
Performs QA review of manufacturing and packaging batch records for commercial product and/or investigational development product (IMP) for accuracy and compliance with GMP requirements.
Utilizes an eQDMS system to enter batch-related information and complete associated batch disposition workflows.
Escalates project/supplier issues and trends to management to ensure timely resolution.
Works collaboratively with vendors, internal quality teams, and cross-functional stakeholders to ensure compliance with local and global regulatory requirements.
Maintains GMP records, including document storage, archiving, and retrieval.
Reviews analytical test results and raw data to ensure results meet specifications and are appropriately documented; approves data in LIMS to support stability studies as needed.
Reviews vendor quality events, deviations, investigations, and change controls alongside executed batch records to assess batch acceptability.
Completes quality event records (e.g., action items, CAPAs, investigations) within the eQMS system as assigned.
Supports quality metrics, dashboards, and management reviews by compiling batch review/release data and handling ad hoc reporting requests.
Supports quality system process improvement projects, including user acceptance and management testing activities.

Qualifications:

Bachelor’s degree in Engineering, Chemistry, Biology, or related scientific field.
2–5 years of experience in the pharmaceutical industry in a Manufacturing, QA, or QC role supporting GMP activities for investigational medicinal product or clinical trial material.
Ability to work independently.
Ability to interact with and resolve issues involving internal stakeholders and GMP vendors in a professional and effective manner.
Ability to manage and prioritize multiple tasks.
Experience with Microsoft Office (Word, Excel, PowerPoint) and collaborative tools such as Teams or SharePoint.
Experience using an eQDMS workflow system.
Strong interpersonal and communication skills.
Thorough understanding of GMP requirements and the drug development process.
Strong analytical problem-solving and decision-making skills.
Ability to identify gaps and risks and propose corrective and preventive actions.

Preferred:

Experience in quality oversight of R&D or clinical-stage products.
Experience working with external vendors.
Experience with batch review and disposition of bulk drug product and/or packaged investigational medicinal product within a QA role.