Environmental Monitoring Supervisor

Are you looking to take on a new management challenge while advancing products into the market? Our client, a well-established, branded organization is looking for a QC Microbiology Supervisor, 2nd Shift to oversee the daily operations of a group of analysts on off shift (2nd or 3rd). The supervisor ensures that all activities within the laboratory are performed in compliance with cGMP and internal written procedures and policies. The supervisor is responsible for scheduling personnel and material resources to ensure that sampling/testing commitments are satisfied and communicate any difficulties to QC management. The supervisor is accountable for the accuracy, integrity, and security of all results generated by the working group. The supervisor measures progress, evaluates results, and takes responsibility for outcomes.

Education and Experience:

Degree in a Life Science (Microbiology preferred) with approx. 8 years of experience in pharmaceutical manufacturing or Associate's Degree in a Life Science field with 8 years' experience and 2 years managing reports in a biology lab

supervisory/leadership experience (approx. 2 years) managing direct reports and performance reviews in a pharmaceutical or lab setting

Responsibilities:

Provides analysts to support monitoring of manufacturing areas and utilities. Provides support to train manufacturing personnel on water sampling, settle plates, RODAC, and air plates. Work with manufacturing to appropriately schedule work or training. Scheduling coordination with first shift and off shift supervision in EM as well.

Write, revise, or review SOP’s, environmental and validation protocols, risk assessments, change controls, deviations, controlled forms. Ensure all assigned timelines are met including reviewing, deviations, projects, etc.

Participate or lead projects and meetings. Make decisions as needed, involving the manager on critical decisions/projects effecting the overall group or external groups.

Participates in personnel decisions (interviewing, hiring, performance appraisals, promotion, disciplinary action, staff development, coaching and counseling) regarding staff.

Maintain aseptic gowning qualification and perform environmental monitoring for each aseptic fill line when analysts need additional support. Act as a backup trainer for EM and Utilities on off shift.

Strong technical knowledge of environmental monitoring and utilities testing (endotoxin, conductivity, bioburden, TOC, MODA)

Thorough knowledge of aseptically filled sterile drugs. Additional knowledge of non-sterile solid doses helpful

Strong mentor for staff with ability to help others develop and maintain a great team

Demonstrate diplomacy and tact to diffuse tense situations and presents arguments to support decision/ point of view