Environmental Monitoring Training Supervisor

Nephron Pharmaceuticals; West Columbia (SC); On-site; USD 70,000 - 100,000; Full time

Job summary

Nephron Pharmaceuticals in West Columbia, SC is seeking an Environmental Monitoring Training Supervisor to oversee the EM training program, gown certification process, and the associated personnel. This position ensures ongoing competency and strict adherence to cGMPs, with collaboration across EM trainers, technicians, and supervisors.

Key duties include planning training timetables and shift schedules for new EM hires, maintaining certification folders, supporting environmental excursion

Qualifications

• BS degree in a related field.
• 3 years pharmaceutical or related industry experience preferred.
• Experience in environmental monitoring preferred.
• Strong knowledge of cGMPs and regulatory requirements.

Responsibilities

• Oversee EM training program for all personnel.
• Coordinate training timetable and shift schedules for new hires and trainers.
• Establish a constructive learning environment with trainers and trainees.
• Provide regular feedback on progress and areas for improvement.
• Oversee trainings performed by shift leadership and management.
• Verify certification forms and update the training dashboard.
• Coordinate with EM Gown Coordinator for gowning certification.
• Apply EM sampling procedures and knowledge of MODA, PowerBI, LabVantage.
• Assist excursions investigations and corrective actions.
• Perform back-up support for EM activities and ensure accurate batch records.
• Review EM data entry and paperwork.
• Conduct EM data trend analyses.
• Assist EMPQs and other EM projects.
• Communicate EM observations to EM Program Manager and QA.

Skills

cGMPs knowledge

PowerBI

LabVantage

MODA

Aseptic gowning

MS Excel

MS Word

Documentation

Training coordination

Education

BS Degree

3 years pharmaceutical experience

Tools

Non-viable counter

Viable air sampler

Job description

Nephron Pharmaceuticals

Environmental Monitoring Training Supervisor manages and provides oversight of the Environmental Monitoring (EM) training program, gown certification process, and the associated personnel.

Assists EM Program Manager with investigations of environmental excursions, as needed. Manages and verifies all EM employees training certifications, folders, and forms.

Essential Duties and Responsibilities:

• Manages continuous training program for all EM personnel.
• Manages, prepares, and coordinates a training timetable, as well as shift schedule, for new EM hires and EM Trainers.
• Establishes a constructive learning environment and relationship with trainers and trainees to encourage advice seeking and maximize learning opportunities.
• Manages and provides regular feedback of trainer and trainee's progress, including achievements; identifies any areas for improvement as early as possible, and takes appropriate steps to facilitate improvement in performance or recommend other actions as necessary.
• Oversees trainings performed by shift leadership, trainers, and management.
• Verifies various certification forms and updates the training dashboard on SharePoint.
• Oversees and coordinates with EM Gown Coordinator for Gowning Certification Program.
• Utilizes strong grasp of EM sampling procedures, while maintaining knowledge of MODA, LabVantage, PowerBI, and all required EM paperwork.
• Assists with environmental excursion investigations and lab events, and the implementation of corrective actions, as needed.
• Performs back-up support, when necessary, for all EM activities, and ensures accuracy and completeness of MODA reports and batch records.
• Assists in the daily review of EM technicians' data entry and paperwork, as needed.
• Reviews EM data and assists in trend analysis utilizing MODA, PowerBI, and LabVantage, as needed.
• Assists with the execution of EMPQs and other special EM projects, as needed.
• Communicates EM-related observations, issues, problems, discrepancies, and any violations of company policies or procedures to EM Program Manager, Quality management, or designee.

Supplemental Functions:

• Performs other duties as assigned.

Job Specifications and Qualifications:

Knowledge & Skills:

• Willingness to participate in training and gain other certifications, as needed.
• Great communication, documentation, and time management skills; and must be able to multi-task.
• Experience in general computer operation (including MS Word and MS Excel), Non-viable particulate counter, Viable air sampler, Aseptic gowning; familiarity with cGMPs and regulatory requirements is required.
• Excellent aseptic technique and expertise of cleanroom classifications (ISO 14644).
• 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.
• Must have strong organizational skills and be able to manage multiple projects or assignments at one time.
• 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 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.

Education/Experience:

• Regionally accredited BS Degree and/or 3 years Pharmaceutical or related industry experience, preferred.
• Prior Environmental Monitoring experience preferred.

Working Conditions / Physical Requirements:

• This position requires bending, typing, lifting (up to 40 1bs.), standing, sitting and walking throughout the facility.
• Salary range: Based on experience.

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