QA INSPECTOR I in SOMERSET, New Jersey at ASPIRE PHARMACEUTICALS INC

• Ensure compliance with current Good Manufacturing Practices (cGMP), FDA regulations, company SOPs, and quality standards during all phases of manufacturing and packaging operations.
• Perform sampling of raw materials, packaging materials, in-process materials, finished products, microbiological samples, validation samples, stability samples, and controlled samples in accordance with approved procedures.
• Review incoming raw material and packaging material documentation for completeness, accuracy, and compliance with established procedures.
• Prepare, issue, and maintain receipt, quarantine, and release labels for raw materials and packaging components.
• Perform routine calibration verification of in-house balances and maintain calibration records.
• Conduct room clearance, equipment clearance, and manufacturing and packaging line clearance inspections prior to production activities.
• Perform in-process quality inspections during manufacturing and packaging operations according to batch manufacturing records (BMRs), batch packaging records (BPRs), and established procedures.
• Collect, prepare, label, and submit bulk and finished product samples for Quality Control testing and QA retain samples.
• Review manufacturing and packaging logbooks for completeness, accuracy, and compliance.
• Perform equipment swab sampling and cleanliness verification as required.
• Verify packaging labels, printed components, and packaging materials before production begins.
• Verify cleaning activities have been completed before manufacturing or packaging equipment is released for use.
• Conduct visual inspections of labeling components and prepare inspection documentation.
• Issue labeling components according to packaging orders and monitor label room activities for compliance.
• Review batch manufacturing and packaging documentation for completeness, proper signatures, data accuracy, reconciliations, yields, and compliance before authorizing progression to the next processing step.
• Maintain proper storage, issuance, periodic inspection, and destruction of retain samples in accordance with SOPs.
• Verify functionality and operational readiness of manufacturing and packaging equipment and associated controls during production.
• Utilize business systems and software including Microsoft Office, SYSPRO, Rite-Scan, QR Code systems, and other electronic applications to document and track quality activities.
• Promptly report quality issues, deviations, or non-conformances to QA management.
• Support internal audits, inspections, investigations, and continuous improvement initiatives as assigned.
• Perform other duties and responsibilities as assigned.

Education & Experience:

• High school diploma or equivalent required; an Associate's degree in a scientific or technical field is preferred.
• 1-2 years of experience in Quality Assurance, Quality Control, manufacturing, or another regulated industry; pharmaceutical or dietary supplement experience is preferred.
• Basic knowledge of current Good Manufacturing Practices (cGMP), FDA regulations, Good Documentation Practices (GDP), and quality systems.
• Strong attention to detail with the ability to accurately inspect materials, review documentation, identify discrepancies, and maintain accurate records.
• Proficient in Microsoft Office applications and able to learn and effectively use ERP and quality management systems such as SYSPRO, Rite-Scan, barcode/QR code systems, or similar software; strong communication, organizational, and teamwork skills.