What are the responsibilities and job description for the Quality Associate II position at Advanced Clinical?
We are currently searching for a skilled professional to join a well-known client’s team as a remote or hybrid Quality Associate in Princeton, NJ. Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.
RESPONSIBILITIES
• Ensure GMP compliance for outsourced clinical manufacturing, packaging, labeling, and testing activities.
• Perform QA review of manufacturing and packaging batch records for commercial products and/or Investigational Medicinal Products (IMP) to ensure accuracy and GMP compliance.
• Use TrackWise Digital eQDMS to enter batch-related information and complete associated batch disposition workflows.
• Escalate project or supplier issues and trends to Quality Management to ensure timely resolution.
• Collaborate with vendors, the Quality department, and cross-functional teams to ensure compliance with local and global regulatory requirements.
• Maintain GMP records, including document storage, archiving, and retrieval.
• Review analytical test results and raw data to ensure results meet specifications and are properly documented; approve data in LIMS to support stability studies as needed.
• Review vendor quality events, deviations, investigations, and change controls alongside executed batch records to assess batch acceptability.
• Complete Quality Event–related records in TrackWise (including Action Items, CAPA, and investigation records) as assigned.
• Support quality metrics, dashboards, and management reviews by compiling batch review/release data and responding to ad hoc reporting requests.
• Support TrackWise Digital quality process improvement initiatives, including UAM/UAT testing.
EXPERIENCE
• 2–5 years of pharmaceutical industry experience in Manufacturing, QA, or QC supporting GMP activities for Investigational Medicinal Products / Clinical Trial Materials.
• Ability to work independently and manage multiple priorities.
• Strong ability to collaborate with internal stakeholders and GMP vendors in a professional and effective manner.
• Proficiency with Microsoft Office (Word, Excel, PowerPoint) and collaboration tools such as Teams and SharePoint.
• Experience using TrackWise Digital or a similar eQMS workflow system.
• Excellent 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 risks or gaps and propose corrective and preventive actions.
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Preferred Qualifications
• Experience providing quality oversight for R&D or clinical-stage products.
• Experience working with external vendors.
• Experience with batch review and disposition of bulk drug product and/or packaged IMP within a QA role.
EDUCATION
• Bachelor’s degree in Engineering, Chemistry, Biology, or a related scientific discipline.
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Full-time employees are also eligible for benefits options such as health coverage, life insurance, disability insurance, and 401k benefits.
At Advanced Group, our commitment to diversity and inclusion in every part of our organization is crucial to fulfilling our mission and demonstrating our REAL values. Advanced Group is committed to providing employment opportunities without regard to sex, race, color, age, national origin, religion, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, disability, veteran status, or any other basis protected by applicable federal, state or local law.
Advanced Group complies with federal and state disability laws and makes reasonable accommodations for applicants and candidates with disabilities. If a reasonable accommodation is needed to participate in the job application or interview process, please contact accommodationrequest@advancedgroup.com.