Corporate StatementNephron Pharmaceuticals Corporation 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, ophthalmics, 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. Nephron is currently working on research and development projects that include over 50 new products. 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 Puerto Rico, with additional sales channels throughout South America, the Middle East, and Europe.
Nephron exists to provide top-quality, affordable medications to everyone.Position Summary
- Provides oversight of the day-to-day technical operations of Environmental Monitoring (EM), including but not limited to capacity planning, protocol development, process changes, data evaluation, and resource management in a high-growth, fast-paced, dynamic work environment while ensuring compliance with FDA regulations.
- Leads EM-related projects and process improvements, including, EMPQs, Media Fills, investigation excursions, personnel training, and any other special projects.
- Assists with additional work duties or responsibilities as evident or required.
Primary Accountabilities:
NOTE: The primary accountabilities below are intended to describe the general content of and requirements of this position and are not intended to be an exhaustive statement of duties. Incumbents may perform all or most of the primary accountabilities listed below. Specific tasks or responsibilities will be documented in the incumbents' performance objectives as outlined by the incumbents' immediate supervisor or manager.
- Provides technical leadership for the Environmental Monitoring team to ensure regulatory requirements are met.
- Leads capacity planning initiatives for the EM program; this includes developing and/or reviewing new equipment resourcing, writing and reviewing new processes for onboarding new cleanroom suites, EMPQs, and other EM processes and initiatives.
- Develops and/or reviews documentation related to new process development such as protocols, EMPQs, SOPs, and Quality Improvement Plans, as applicable.
- Works with shift supervisors to ensure EM supply and material inventory is maintained appropriately within the Microbiology Lab and cleanrooms; the management of inventory in regards to various EM-related studies and protocols is essential.
- Reviews and drafts procedures as necessary; supports training initiatives for staff in regards to new processes, procedures, or equipment.
- Works with Microbiology Project Manager(s) to ensure coordinated initiatives are assigned and communicated between all Microbiology personnel. Ensure all project deadlines are met, as needed.
- Participates as an SME for the EM program in regulatory inspections as well as inspection readiness activities.
- Identifies resources needed for dynamic, ongoing projects throughout the Microbiology department; bridges the gap between Microbiology and other departments in terms of communication and coverage for special projects, EMPQs, and other initiatives.
- Assists in fostering/establishing a constructive learning environment and relationship with incoming EM Technicians; encourages all staff to seek and maximize learning opportunities through the department.
- Communicates EM-related observations, issues, problems, discrepancies, and any violations of company policies or procedures to EM Program Manager, Director of Microbiology, VP of Microbiology, or designee.
- Assists in other duties as assigned or apparent.
Knowledge, Skills & Abilities:
• Bachelor's Degree or related industry experience preferred
o Minimum of 3 years' experience in a cGMP-related environment.
• Experienced in general computer operation (including Microsoft Office) and navigation of environmental monitoring sample databases (i.e. MODA and LabVantage).
• Must have a technical writing background and can provide a writing sample upon request.
• Thorough knowledge of cGMP and regulatory requirements, including but not limited to: FDA Guidance for Industry, Code of Federal Regulations, USP, Annex 1, and ISO, as applicable.
• Knowledgeable of cleanroom design and classifications (ISO 14644). Must also be proficient in the operation of non-viable particulate counters, viable air samplers, and aseptic techniques/gowning.
• Great communication, documentation, problem solving, and time management skills; must be able to multitask.
o Communicates effectively and consistently with all levels of staff.
- Flexible and open to receiving and providing training in other departmental areas.
- Must have strong organizational skills, attention to detail, and ability to manage multiple projects or assignments at one time; must also possess the initiative and follow through to implement, track, and achieve on-time completion of projects as assigned.
• Specific expertise, skills, and knowledge within microbiology gained through education and experience.
• The ability and willingness to change direction and focus to meet shifting organizational and business demands.
• The ability to create and contribute to a work environment that values people, encourages trust, teamwork, and open communication, and provides participation, learning, feedback and recognition.
• The ability to effectively manage one self, demonstrates integrity, be productive under pressure, and achieve development goals.
• The ability to take strategic objectives and accept accountability to drive results through effective actions.
• Position requires bending, typing, lifting (up to 20lbs), reaching, vision, standing (30%), sitting (40%), walking (30%), talking and hearing.
• Position encounters the following environmental factors: heat, water, hazardous materials including biohazardous waste, laboratory chemicals and other non-specified hazardous materials that are project specific.
• Incumbents are required to wear safety glasses, hearing protection, PPE Gowning, and other non-specified protective equipment as necessary.
- Salary range: Based on experience
EEO Statement:
Nephron is an equal employment opportunity employer and does not discriminate against employees or job applicants on the basis of race, religion, color, sex, sexual orientation, gender identity, age, national origin, disability, status as a protected veteran, pregnancy, marital status, genetic information, childbirth, medical needs arising from pregnancy and childbirth and related medical conditions, including lactation, or any other consideration made unlawful by applicable federal, state or local law.
Nephron Pharmaceuticals is a drug free workplace.
