Environmental Monitoring Training Coordinator

Description

Environmental Monitoring Training Coordinator assists in the organization and oversight of Environmental Monitoring (EM) training program, and associated personnel. Communicates and manages logistics for training of EM employees. Responsible for management of training certifications, folders, and forms. Facilitates training of Environmental Monitoring Technicians on fundamental tasks, including but not limited to general job knowledge, Water for Injection sampling, and plate reads. Assists in the management of materials for items required for training.

Essential Duties and Responsibilities:

• Assists in the management, preparation, and coordination of training in accordance with the training timetable, for EM personnel.
• Establishes a constructive learning environment and relationship with trainees to encourage advice seeking and maximize learning opportunities.
• Provides EM Management with regular feedback for trainee progress where appropriate including progress, scheduling concerns, and areas of improvement.
• Assists with oversight of trainings performed by shift supervisors, trainers, and management.
• Verifies various certification forms and updates the training dashboard on SharePoint.
• 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 in the implementation of corrective actions, as needed.
• Assists with completion of document revisions and/or change controls related to the Environmental Monitoring program, as needed.
• 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.
• Communicates EM-related observations, issues, problems, discrepancies, and any violations of company policies or procedures to EM Training Manager, 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.
• Experience in general computer operation (including MS Word and MS Excel), Non-viable particulate counter, Metasys, 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 with Pharmaceutical or related industry experience, preferred.
• Prior Environmental Monitoring and/or Pharmaceutical Industry experience required.

Working Conditions / Physical Requirements:

• This position requires bending, typing, lifting (up to 40 lbs.), standing, sitting and walking throughout the facility.
• Hours of work: Monday thru Friday on an 8-hour shift, or as needed based on company demand.
• Salary range: Based on experience.