Microbiology Lead Environmental Monitoring Technician

NEPHRON SC, LLC•West Columbia, SC

11d•Onsite

About The Position

Essential Duties and Responsibilities: Coordinates daily activities to monitor environment, air quality, and personnel samples in production area and complete daily review of aseptic monitoring data entry and/or form completion. Ability to monitoring in all ISO classified production areas. Coordinates sampling program for facility water for injection (WFI) system. Assists with training of newly hired EM Technicians; also ensures the continuous training of all EM Techs in all cleanroom production areas, and with all new equipment and machines (including, but not limited to, Continuous Particle Measuring System). Executes data entry and/or form completion and verification. Performs additional laboratory tasks and assists in EM-related projects as needed. Ensures EM Technicians are utilizing MODA per procedure, and assist Microbiology Management in providing trend data and reports for analysis. Develops and distribute daily EM schedule and ensure it is followed. Covers monitoring activities, as necessary, to ensure support in all areas are covered each shift. Maintains inventory necessary for EM program operation. Communicate quality-related observations, issues, problems, discrepancies, and any violations of company policies or procedures to the EM Supervisor, EM Assistant Manager(s), EM Program Manager and/or Director of Microbiology or designee. Supplemental Functions: Performs other duties as assigned. Job Specifications and Qualifications: Knowledge & Skills: Team player – must be able to interact with multiple company departments. Flexible and open to receive and provide training in other areas and accept new changes in order to achieve department demands. Must have strong organizational skills and be able to manage multiple projects or assignments at one time. The ability to set clear targets and use performance measures to assess risk and opportunities in order to effectively manage the assets of the business. Experience in operation of non-viable particulate counter, Continuous Particle Measuring System, Hygrometer, Viable air sampler, and successful aseptic gowning. Specific expertise, skills, and knowledge within Microbiology gained through education and experience. The ability to manage a multitude of resources; and to be accurate and current with data and information. A broad perspective that aligns decisions to organizational objectives and long term consequences of day-to-day activities. The ability to take strategic objectives and accept accountability, and to motivate and influence others to drive results through effective actions. The ability and willingness to change direction and focus to meet shifting organizational and business demands. The ability to effectively manage one’s self, demonstrate integrity, be productive under pressure, and achieve development goals. Incumbents required to wear specified protective equipment, as necessary. Education/Experience: Associates of Science degree minimum, Bachelor’s degree preferred. 1 – 2 years of experience in pharmaceutical industry or clinical background with cGMP knowledge preferred. Working Conditions / Physical Requirements: This position requires bending, typing, lifting (up to 40 1bs.), reaching, vision, talking, hearing, standing, sitting, and walking throughout the facility. Hours of Work: 12-hour rotating shift. Salary range: Based on experience.

Requirements

Team player – must be able to interact with multiple company departments.
Flexible and open to receive and provide training in other areas and accept new changes in order to achieve department demands. Must have strong organizational skills and be able to manage multiple projects or assignments at one time.
The ability to set clear targets and use performance measures to assess risk and opportunities in order to effectively manage the assets of the business.
Experience in operation of non-viable particulate counter, Continuous Particle Measuring System, Hygrometer, Viable air sampler, and successful aseptic gowning.
Specific expertise, skills, and knowledge within Microbiology gained through education and experience.
The ability to manage a multitude of resources; and to be accurate and current with data and information.
A broad perspective that aligns decisions to organizational objectives and long term consequences of day-to-day activities.
The ability to take strategic objectives and accept accountability, and to motivate and influence others to drive results through effective actions.
The ability and willingness to change direction and focus to meet shifting organizational and business demands.
The ability to effectively manage one’s self, demonstrate integrity, be productive under pressure, and achieve development goals.
Incumbents required to wear specified protective equipment, as necessary.
Associates of Science degree minimum
1 – 2 years of experience in pharmaceutical industry or clinical background with cGMP knowledge preferred.
This position requires bending, typing, lifting (up to 40 1bs.), reaching, vision, talking, hearing, standing, sitting, and walking throughout the facility.

Nice To Haves

Bachelor’s degree preferred.
1 – 2 years of experience in pharmaceutical industry or clinical background with cGMP knowledge preferred.

Responsibilities

Coordinates daily activities to monitor environment, air quality, and personnel samples in production area and complete daily review of aseptic monitoring data entry and/or form completion.
Ability to monitoring in all ISO classified production areas.
Coordinates sampling program for facility water for injection (WFI) system.
Assists with training of newly hired EM Technicians; also ensures the continuous training of all EM Techs in all cleanroom production areas, and with all new equipment and machines (including, but not limited to, Continuous Particle Measuring System).
Executes data entry and/or form completion and verification.
Performs additional laboratory tasks and assists in EM-related projects as needed.
Ensures EM Technicians are utilizing MODA per procedure, and assist Microbiology Management in providing trend data and reports for analysis.
Develops and distribute daily EM schedule and ensure it is followed.
Covers monitoring activities, as necessary, to ensure support in all areas are covered each shift.
Maintains inventory necessary for EM program operation.
Communicate quality-related observations, issues, problems, discrepancies, and any violations of company policies or procedures to the EM Supervisor, EM Assistant Manager(s), EM Program Manager and/or Director of Microbiology or designee.
Performs other duties as assigned.