Supervisor - EM Comp Group

Job Description

The Environmental Monitoring (EM) program is made up of two distinct sections, data collection and data analysis. The laboratory activities include environmental monitoring of ISO-classified areas, sampling of products, reading, recording and verifying results, data entry, writing and updating procedures as well as other tasks as required. This EM Supervisor position is responsible for the scheduling, sampling and collection of the EM samples and Utilities as described in the essential responsibilities.

In addition, the EM supervisor helps with audit responses reports for Actions, Alerts, Incidents and is responsible for keeping management informed of potential problems associated with the monitored systems. Additional tasks include reviewing and comparing published guidelines, and USP revisions to the EM program keeping abreast of EM industry trends and providing supervision to a team of EM technicians and Specialist.

• Conduct and/or train EM personnel on performing investigations.
• Review lab results for accuracy and compliance with SOPs.
• Serve as a back-up for all lab personnel (water testing, particle monitoring, EM monitoring, HEPA testing, etc.).
• Administer the EM Database: oversee the training of EM technicians on the use of the database and ensure database accuracy.
• Review and/or prepare SOPs as needed for EM.
• Establish objectives and conduct performance reviews with direct report personnel.
• Conduct investigations related to EM data excursions and provide the written assessments as needed for Action/Alert Investigations and Level 1/2/3 Incidents.
• Monitor EM regulatory agency changes, guidance documents and USP revisions and recommend necessary changes.
• Manage the data entry and issuance and disposition of all EM data forms.
• Notify management of possible problems with ISO-classified areas, WFI system, and other areas related to EM.

• Bachelor of Science Major(s):
  Biology, Chemistry, or related hard science required
• 6 months of related leadership experience in lieu of specific hard science degree; degree still required
  -OR- 4 years solid QA/QC, Pharma Manufacturing or related Supervisory experience in lieu of degree required.
• Minimum 2 years of related pharmaceutical experience in aseptic processing, environmental monitoring, cGMP and microbiological techniques required.
• Lead experience required.
• Laboratory experience required.
• Microsoft Word, Excel and PowerPoint required.
• Mechanical aptitude desired required.
• Knowledge of statistics and college level math desired.
• Managing conflict and influencing outcomes required.
• Communicate effectively in both written and verbal formats required.
• Demonstrate strong interpersonal skills and manage conflict required.
• Effectively communicate with all levels of personnel to obtain information for investigations required.
• Sufficient environmental monitoring experience to be able to evaluate environmental data and analyse findings in respect to facility and product risk required.
• Ability to effectively summarize and report conclusions and recommendations in both verbal and written form required.
• Evaluate situations to determine appropriate course of action to environmental concerns required.
• Strong trouble shooting and investigative techniques are required.
• Must be able to perform investigations looking at the entire picture and evaluate what may be affected, what needs to be done and who needs to be notified required.
• Communicate effectively to all levels of personnel within and outside of the Quality Unit to collect information required to perform detailed and thorough investigations and provide effective recommendations for resolutions to investigations required.
• Resolve resistance dealing with cost, time and resource issues relating to necessary correction actions required.

• Ability to lift 30 pounds unassisted
• Exposure to allergens
• Working in aseptic areas
• Working in confined spaces
• Prolonged standing
• Twisting
• Must be able to maintain gown certification
• Routine environment with simple rules and detailed instructions.
• Repetitive/patterned situations: choices of learned solutions.
• Differing situations: search for solutions or new…