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.
