Jobs at Nephron Pharmaceuticals Corporation

Oversees laboratory instrumentation programs in a chemistry laboratory, including preventive maintenance, qualification, troubleshooting, supplies, SOPs, logbooks, and compliance documentation. Maintains HPLC, GC, and other analytical instruments while supporting cGMP quality systems and FDA, USP, and industry requirements. Provides technical direction, manages projects and resources, and identifies cost-saving opportunities compared with vendor maintenance contracts.

Coordinates and delivers employee training programs, including orientation, onboarding, OJT certification, cGMP, leadership, contractor, and instructor-led training. Administers LMS, QMS, training dashboards, records, and certification documentation. Partners with leaders to assess training needs, develop materials, measure effectiveness, conduct compliance audits, and maintain accurate employee training files. Also facilitates tours, workshops, webinars, and continuous improvement initiatives in a regulated pharmaceutical manufacturing environment.

Manages DEA compliance and controlled-substance programs, including procedures, inventories, reporting, registrations, records, inspections, investigations, corrective actions, and staff training. Serves as the organization’s controlled-substance subject matter expert and power of attorney. Coordinates DEA and state regulatory requirements, supports FDA inspections, maintains inspection readiness, and improves tracking and reconciliation systems. The role requires pharmaceutical and controlled-substance experience, regulatory knowledge, technical writing, and root-cause analysis skills.

Manages document control operations in a regulated pharmaceutical environment, including document lifecycle management, batch records, media fill documentation, records retention, audit readiness, and quality-system support. Leads and develops the Document Control team, ensures compliance with cGMP, FDA, 21 CFR Part 11, and ALCOA+ principles, and coordinates with Quality, Manufacturing, and Product Development teams.

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.

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.

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.