ASPIRE PHARMACEUTICALS INC

Job Description Job Description Position Description: Position SummaryThe QA Inspector I is responsible for supporting Quality Assurance activities by ensuring products are manufactured, packaged, and released in compliance with current Good Manufacturing Practices (cGMP), FDA regulations, company Standard Operating Procedures (SOPs), and applicable quality standards. This role performs in-process inspections, material sampling, line clearance, documentation review, equipment verification, and quality monitoring throughout manufacturing and packaging operations.Essential Duties and ResponsibilitiesEnsure 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.