Environmental Monitoring Program Supervisor

Description

Environmental Monitoring Program Supervisor provides supervision and oversight of the Environmental Monitoring (EM) activities and personnel during shift. Assists Microbiology department management with environmental excursion investigations and quality events. Performs back-up support for EM activities.

Essential Duties and Responsibilities:

• Coordinates shift activities to monitor environment, air quality, and personnel samples in production area, as well as the review of EM technicians’ data entry and paperwork.
• Oversees and coordinates sampling program for facility water for injection (WFI).
• Participates in back-up monitoring activities, when necessary, to assure proper shift coverage.
• Ensures EM Technicians are utilizing MODA per procedure, and assists Microbiology Management in trending and generating reports for analysis.
• Reviews EM data utilizing computer programs, including MODA and LabVantage.
• Responsible for providing updates in Paylocity for shift staff, as well as completing employee performance evaluations with support from EM management.
• Assists with the execution of Media Fill validations, EMPQs, and other special projects, as needed.
• Ensures compliance with and provides input for the EM shift schedule.
• Assists in maintaining inventory in the EM area.
• Communicates EM-related observations, issues, problems, discrepancies, and any violations of company policies or procedures to EM Assistant Manager, EM Program Manager, or designee.

Supplemental Functions:

• Performs other duties as assigned.

Requirements

Knowledge & Skills:

• Experience assisting in the monitoring of all production areas and personnel.
• Experience with general computer operation (including MS Word, MS Excel, and data entry), 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).
• Knowledge of USP, CFR, FDA, and related regulatory guidance as it applies to pharmaceutical manufacturing.
• Great communication, documentation, and time management skills; must be able to multitask.
• Flexible and open to receiving and providing training in other departmental areas.
• Must have strong organizational skills and ability to manage multiple projects or assignments at one time.
• 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.
• 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.
• A broad perspective that aligns decisions to organizational objectives and long term consequences of day-to-day activities.
• 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:

• Bachelor’s Degree with 3 years Pharmaceutical or related industry experience preferred.

Working Conditions / Physical Requirements:

• This position requires bending, typing, lifting (up to 40 1bs.), standing, sitting and walking throughout the facility.