Microbiology Environmental Monitoring Supervisor 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. 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 supervision and oversight of the Environmental Monitoring (EM) activities and personnel.

· Assists Microbiology department management with EM-related projects and processes, including EMPQs, Media Fills, investigation excursions, training of personnel, and any other special projects.

· Works alongside EM Leads and EM Management to coordinate completion of training and oversee daily EM operations.

· 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 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.

· Ensures EM Leads create daily EM schedules and coordinate shift activities to monitor environment, air quality, and personnel samples in all production and supporting areas. Assist with the creation of daily EM schedules in the absence of the EM Lead.

· Responsible for checking in with the Shift Lead throughout the shift to maintain awareness of production schedules and ensure compliance with the EM shift schedule.

· Ensures Shift Leads provide direction, oversite and coordination of sampling program operations for facility water systems. Assist with the oversite and coordination of facility water system sampling in the absence of EM Lead.

· Coordinates and/or performs back-up support when necessary for all EM activities.

· Responsible for reviewing EM sampling data for accuracy and completion both in databases (MODA and LabVantage) and on paperwork.

· Responsible for Paylocity timecard review and approvals for shift personnel.

· Responsible for the completion and submission of employee performance evaluations for shift personnel.

· Ensures that the EM Lead oversees the creation of the daily plate read list and sample enumeration/verification.

· Coordinates EM coverage for Media Fill validations, EMPQs, and other special projects, as needed.

· Assists in maintaining EM supply inventory within Microbiology Lab and cleanrooms.

· Coordinates weekly audits of all cleanroom areas and EM equipment, as well as weekly lab cleanings.

· Responsible for completing and reviewing all applicable shift checklists and communication forms.

· Responsible for communicating EM-related observations, issues, problems, discrepancies, and any violations of company policies or procedures to EM Assistant Managers, EM Program Manager, Microbiology Management, Quality Management, and/or designee.

· All other duties as assigned or required.

Knowledge, Skills & Abilities:

· Bachelor's Degree preferred, with 2-years Pharmaceutical or related industry experience.

· Prior EM and/or Pharmaceutical Industry experience.

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

· Experienced in general computer operation (including Microsoft Office) and navigation of EM sample databases (including MODA and LabVantage). Knowledgeable of cGMP and regulatory requirements, and proficient in operation of non-viable particulate counters, viable air samplers, and aseptic techniques/gowning.

· Knowledgeable of cleanroom design and classifications (ISO 14644).

· Must have strong communication, documentation, and time management skills.

· Must have strong organizational skills and be able to manage multiple projects or assignments at one time.

· Must be a team player and be able to interact with multiple company departments.

· The ability and willingness to change direction and focus to meet shifting organizational and business demands

· Must be flexible and open to receiving and providing training in other departmental areas.

· 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 oneself, demonstrate 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

· Hours of work: 12-hour shift, or as needed based on company demand.

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 is a drug free workplace.

PI256376367