Environmental Monitoring Program Supervisor

Essential Duties and Responsibilities

• Captures shift activities to monitor environment, air quality, and personnel samples in production area, and reviews EM technicians' data entry and paperwork.
• Oversees and coordinates sampling program for facility water for injection (WFI).
• Participates in back-up monitoring activities to ensure proper shift coverage.
• Ensures EM Technicians are using MODA according to procedures and assists Microbiology Management in trend analysis and report generation.
• Reviews EM data using computer programs such as MODA and LabVantage.
• Updates Paylocity for shift staff and completes employee performance evaluations with EM management support.
• Supports Media Fill validations, EMPQs, and other special projects as needed.
• Maintains compliance with and provides input for the EM shift schedule.
• Maintains inventory in the EM area.
• Communicates EM-related observations, issues, problems, discrepancies, and policy violations to appropriate personnel.

Supplemental Functions

• Performs other duties as assigned.

Requirements

• Experience assisting in the monitoring of all production areas and personnel.
• Experience with general computer operation (MS Word, MS Excel, data entry), non-viable particulate counter, Metasys, Viable air sampler, aseptic gowning, and familiarity with cGMPs and regulatory requirements.
• Excellent aseptic technique and expertise of cleanroom classifications (ISO 14644).
• Knowledge of USP, CFR, FDA, and related regulatory guidance applicable to pharmaceutical manufacturing.
• Great communication, documentation, and time management skills; ability to multitask.
• Flexible and open to receiving and providing training in other departmental areas.
• Strong organizational skills and ability to manage multiple projects or assignments simultaneously.
• Specific expertise, skills, and knowledge within microbiology gained through education and experience.
• The ability and willingness to adapt to changing organizational and business demands.
• The ability to create and contribute to a supportive work environment.
• The ability to manage one's self effectively, demonstrate integrity, handle pressure, and achieve development goals.
• The ability to drive results through effective actions.

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 lbs., standing, sitting, and walking throughout the facility.
• Incumbents are required to wear safety glasses, hearing protection, PPE Gowning, and other non-specified protective equipment as necessary.