Microbiology Environmental Monitoring Trainer at Nephron Pharmaceuticals in West Columbia, South Carolina

Job Description:

Corporate Statement

Nephron 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. In addition to high volume and redundant utility systems, the facility utilizes completely automated manufacturing, packaging, and distribution 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 without human intervention.

As an industry leader in product safety and quality, Nephron produces a variety of inhalation solutions and has distributed over one 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

· Performs on-the-job, group, and one-on-one trainings with Environmental Monitoring (EM) program personnel.

· Coordinates and utilizes different departments and resources for task specific trainings.

· The EM Trainer is an expert on monitoring performed as an EM Technician I, II, and III.

· Assists with additional work duties or responsibilities as evident or required.

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.

Primary Accountabilities:

• Completes all documentation appropriately, and ensures all training requirements for personnel are completed prior to EM technicians performing activity independently.
• Performs continuous training for all EM Technicians and ensures documentation is accurate and current.
• Participates in trainings performed by shift supervisors and managers.
• Utilizes their strong grasp of EM sampling procedures, while maintaining knowledge of MODA, LabVantage, and all required EM paperwork.
• Prepares a training timetable and communicates with trainee; evaluates and communicates training needs to EM management.
• Maintains a database for training, both completed and in-progress.
• Assists in environmental monitoring, as well as collecting water for injection (WFI) samples and sample enumeration, as needed, or during course of training activities.
• Routinely reviews employee errors for training effectiveness; uses GDP and sampling errors as a training tool by reviewing with employees and emphasizing the importance of proper documentation.
• Works collaboratively with management to identify and develop key training needs throughout the EM program.
• Executes data entry and/or form completion accurately; teaches other EM personnel how to appropriately document tasks, whether electronically or physically.
• Establishes a constructive learning environment and relationship with the trainee to encourage advice seeking and maximize learning opportunities.
• Communicates quality-related observations, issues, problems, discrepancies, and any other violations of company policies or procedures to EM Supervisor, EM Assistant Manager, EM Program Manager, Director of Microbiology, or designee.
• Promotes teamwork within the EM team and other departments.
• Flexibility with shift hours.

Knowledge, Skills, & Abilities

· Bachelor's degree with a science background, preferred.

o At least 1 year of Environmental Monitoring or Quality experience in a cGMP pharmaceutical environment.

· 1 – 2 years of training experience preferred.

· Knowledge of cleanroom classifications per ISO 14644.

· Specific expertise, skills, and knowledge within Microbiology gained through education and experience.

· Experience in general computer operation, Non-viable particulate counter, Metasys, Viable air sampler, aseptic gowning, cGMP, and regulatory requirements.

· A broad perspective that aligns decisions and focus to meet shifting organizational and business demands.

· Must be open to receive training in other areas and accept changes in order to achieve department demands.

· Ability and willingness to change direction and focus to meet shifting organizational and business demands.

· Ability to effectively manage oneself, demonstrate integrity, be productive under pressure, and achieve development goals.

· Must have strong organizational and time management skills, and must be able to multi-task.

· Ability to manage a multitude of resources, and to be accurate and current with data and information. The ability and willingness to change direction and focus to meet shifting organizational and business demands.

· The ability to meet deadlines and adapt to department needs and priorities.

· The ability to work independently, demonstrate integrity, and perform under pressure.

· Incumbents are required to wear PPE as assigned by management, as well as comply with proper gowning requirements and other non-specified protective equipment as necessary.

· The ability to spend at least 6 hours a shift on your feet.

· Position requires bending, typing, lifting (up to 20lbs), reaching, vision, standing (30%), sitting (40%), walking (30%), talking and hearing.

· Ability to perform with minimum supervision.

• Salary Range: Based on experience
• Monday – Friday, 8 hours.

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, age, national origin, mental or physical disability of a qualified individual, veteran or military status, pregnancy, marital status, familial status, genetic information, or any other consideration made unlawful by applicable federal, state, or local law.

Nephron Pharmaceuticals Corporation is a drug free workplace.

PI256376397