Quality Control Microbiology Project Manager

Description

Nephron Pharmaceuticals is a privately-owned global leader in the manufacturing of generic drug products, over-the-counter (OTC) drug products and medical devices. Nephron’s products are sterile, preservative and additive free and proudly made in the USA! We are headquartered in West Columbia, South Carolina. Our location provides the ability to develop new devices and medications including respiratory therapies, ophthalmic, and injectables, for in-house or contract manufacturing opportunities.

The facility utilizes completely automated manufacturing, packaging, and distribution systems, in addition to high volume and redundant utility systems, to ensure production system availability. Nephron specializes in Blow-Fill-Seal (BFS) manufacturing, a niche technology that allows a vial of medication to be formed, filled and sealed in a continuous process, in a sterile, enclosed environment and without human intervention.

As an industry leader in product safety and quality, Nephron produces a variety of inhalation solutions, and has distributed over 1 billion doses of respiratory medication per year since 2009. The company’s longstanding relationships with major drug wholesalers allow us to distribute our products to retail pharmacies, mail order pharmacies, hospitals, home care companies, and long-term care facilities. Nephron has a sales force that covers all fifty states and some international territories.

Nephron exists to provide top-quality, affordable medications to everyone. Our quality first culture is built on:
Transformation
, Execution and Trust
.

Quality Control Microbiology Project Manager creates and executes Quality Control Microbiology project work plans and revises, as appropriate, to meet changing needs and requirements of the department. Manages daily operational aspects of Product Development Studies, Equipment Validations, testing procedures, SOPs, and other documents, as needed, and reports project status to upper management. Creates and assigns project review plans; ensures timely completion of all assigned special projects to meet changing needs, requirements, and deadlines of QC Microbiology.

Ensures operational efficiencies and works on continuous improvement efforts. Assist with and tracks QC Microbiology related investigations and trending reports to ensure completion in a timely/effective manner. Ensures appropriate corrective/preventive actions performed by the QC Microbiology team are implemented appropriately and performed within a timely manner. Assists and tracks associated change controls and procedure updates related to QC Microbiology documents and processes.

Assists with managerial review of QC Microbiology samples to ensure samples are processed for release/final disposition.

• Oversees the review of Microbiology documents in the laboratory including logbooks, laboratory notebooks, hood cleaning binders, and others as assigned.
• Conducts final QC Microbiology management review for samples in Lab Vantage and/or paperwork.
• Establishes a timeline for each phase of projects, as well as a completion date for the entire project. Also provides the QC Microbiology background and input for interdepartmental projects.
• Completion of projects and/or ownership of project tasks as assigned or required to meet company objectives.
• Identifies discrepancies and initiates updates to procedures (DOT compliance); assists in coordination of Equipment/Process (E/P) Change Control actions in DOT compliance for QC Microbiology.
• Authors and/or reviews Microbiology related protocols, summary reports, and related documentation as assigned.
• Responsible for Standard Operating Procedure (SOP), MTM, and specification review, revision, and creation.
• Identifies operational and training improvements for QC Microbiology personnel and follows them through to completion.
• Reviews documents for authorization and approval of required or necessary changes and ensures correctness and completeness.
• Collaborates with other Microbiology Project Manager(s) and Management to ensure coordinated initiatives are assigned and effectively…