Jobs at Nephron Pharmaceuticals Corporation

Manages procurement categories by analyzing costs and market trends, negotiating vendor contracts, placing and tracking orders, forecasting demand, managing inventory, resolving pricing issues, and developing category strategies. Collaborates with marketing, buyers, and merchandisers on pricing, promotions, product positioning, and category growth while managing budgets and vendor relationships.

Conducts microbiology research, product development, method validation, investigations, media fills, environmental monitoring, and QC testing in a cGMP environment. Uses specialized microbiological equipment and laboratory systems, generates compliant data, prepares protocols and reports, trends cleanroom results, and supports validation and regulatory documentation. Coordinates project resources, schedules, and technical quality while communicating issues to microbiology leadership.

Supports pharmaceutical document control and the Quality Management System by routing controlled documents, maintaining archives and binders, auditing effective revisions, preparing batch records, creating batch IDs in LabVantage, and responding to document-system requests. The role also performs document formatting, filing, scanning, and administrative support while ensuring compliance with cGMP and FDA requirements.

Lead continuous improvement for change control and document revision, optimize eQMS (Dot Compliance), analyze KPIs and quality data, implement process and system improvements, develop training, support audits, and mentor document control staff across cross-functional teams in a regulated pharmaceutical environment.

Perform USP-based microbiological testing of raw materials, in-process, and finished products (sterility, bioburden, ID, environmental monitoring). Document and report OOS/OOT, assist investigations and sample management, train QC staff, perform method validation when requested, and maintain cGMP-compliant laboratory practices and aseptic technique.

Provide engineering support for MS&T: maintain and control CAD drawings, support cleanroom construction and capital projects, assist equipment procurement/commissioning, troubleshoot facility systems, manage engineering documentation, ensure cGMP compliance, and oversee stability chamber qualification, calibration, and inventory.

The Quality System Scientific Specialist Tier III ensures compliance with quality standards, performs Quality Assurance reviews, and analyzes discrepancies in pharmaceutical processes while adhering to regulatory requirements.

Conduct and document microbiology investigations to ensure FDA and cGMP compliance, manage deviations, CAPAs, and quality events, coordinate cross-functional training and reporting, maintain SOPs and electronic investigation logs, and prepare trending and investigation reports.