Program Manager – External EM Program
The External Environmental Monitoring Program Manager manages and oversees performance of the External Environmental Monitoring (EM) Program, including client interface/interaction, personnel, operations, and special projects. Works with other departments to ensure timely completion of routine and special projects and manages effective personnel workloads to meet client needs. Assists with additional work duties or responsibilities as evident or required.
Primary Duties and Responsibilities
- Ensures staff training is complete and remains current.
- Reviews and approves documents for authorization and approval of required or necessary changes to ensure accuracy and completeness.
- Manages the writing and review of procedures.
- Assists the Director of Microbiology and/or upper management with project management in regards to investigations, planned deviations, and CAPA systems.
- Ensures the purchase of required sampling/testing materials, equipment, and services, as well as scheduling the service and maintenance required by outside providers is completed.
- Oversees or performs the review of initiated reports, EMPQs, protocols, summary reports, trending reports, excursions, quality events, and other materials, as required.
- Manages all personnel responsible for sample collection, document review, environmental investigations, EMPQs, and other special projects to ensure completion.
- Oversees all external EM Programs to ensure complete management of client EM programs utilizing client SOPs and quality systems.
- Manages and coordinates troubleshooting within the EM department.
- Assists in the management of company initiatives, campaigns, and special projects.
- Communicates EM-related observations, issues, problems, discrepancies, and any violations of company or client policies or procedures to the Director of Microbiology, upper management, and/or designee.
- Frequent travel to clients’ facilities required.
- All other duties as needed or required.
- This position requires a Bachelor’s degree in Biology or a related discipline.
- Prior Pharmaceutical Industry and Management experience, with the ability to supervise, train, and discipline employees that are working remotely.
- Experience with USP Guidelines, cGMP, Aseptic Processing, Aseptic Environmental Monitoring Techniques, and Microbiological quality control testing.
- Highly organized, with great written and oral communication skills.
- Specific expertise, skills, and knowledge within Microbiology gained through education and experience.
- The ability to manage oneself effectively, demonstrate integrity, be productive under pressure, and achieve developmental goals.
- Possess a strong attention to detail.
- An ability to manage a multitude of resources and to be accurate and current with data and information.
- The ability and willingness to change direction and focus to meet shifting organizational and business demands.
- A broad perspective that aligns decisions to organizational objectives and long-term consequences of day-to-day activities.
- The ability to take strategic objectives and accept accountability, motivate and influence others, think globally, and leverage diversity.
- The ability to set clear targets and use performance measures to assess risk and manage opportunities effectively.
Minimum Skills Requirements:
- Demonstrated skills in laboratory techniques.
- Solid computer skills.
- Knowledge of safe laboratory practices, including the proper procedures in handling chemicals and samples.
- Must be a team player with integrity and concern for the quality of Company products, services and staff members.
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