Jobs at The Ritedose Corporation

Leads technical and commercial execution of sterile BFS pharmaceutical programs from feasibility and technology transfer through validation, launch, and commercial supply. Serves as the primary client contact, directs cross-functional teams, manages schedules, risks, scope, change orders, regulatory deliverables, budgets, and audits. Mentors project managers, supports PMO governance, and improves project standards, dashboards, and stage-gate processes. The role is on-site in Columbia, South Carolina, with access to manufacturing and laboratory areas.

Performs pharmaceutical QC microbiology testing, environmental and personnel monitoring, microbial enumeration and identification, utility and product testing, data review, equipment maintenance, investigations, audit support, SOP training, and laboratory inventory and housekeeping. Ensures accurate documentation and compliance with cGMP requirements while supporting special projects and microbial culture collection maintenance.

Lead QA oversight for manufacturing process monitoring, process control, and investigations to ensure cGMP and regulatory compliance. Manage and mentor QA staff, lead complex investigations and root cause analyses, approve GMP system changes, participate in audits, drive continuous improvement, and maintain effective quality systems across pharmaceutical manufacturing and distribution.

Lead regulatory strategy and execution for ANDA and customer-led global submissions, manage FDA submissions and responses, draft labeling, oversee lifecycle activities and adverse event reporting, mentor RA associates, monitor regulations, and support due diligence and partnerships.

Act as primary customer contact to manage inquiries, documentation requests, and project status updates. Coordinate communication between customers and internal teams, maintain portals and records, support audits and site visits, perform data collection/trending, and drive timely resolution of customer requests.

Perform environmental, personnel, raw material, in-process and final product microbiological testing; enumerate and identify organisms (culture, Gram-stain, VITEK MS); enter and review data, maintain equipment calibration and inventory, assist with investigations, audits, training and special projects, and maintain microbiology lab cleanliness and culture collection.