The Environmental Monitoring Supervisor serves as the program owner for the Environmental Monitoring (EM) program. This position provides subject matter expertise to the EM team and manages the EM group and compliance activities to achieve key site and corporate objectives.
Principal Responsibilities
- Manages the hiring, training, and performance management of EM personnel.
- Provides subject matter expertise and assistance to the EM program.
- Manages the EM group to achieve compliant testing in a timely manner.
- Manages EM investigations and drives any corrective actions.
- Owns the EM program and ensures that all tracking, trending, and reporting of the EM data is completed.
- Provides overall leadership to EM group regarding cGMP compliance improvement and enhancement.
- Drives Quality consistency through reviewing/revising various EM SOPs to ensure adequacy under normal EM conditions.
- Works with other Managers/Supervisors and EM technicians to address any laboratory concerns regarding quality, safety, methods, procedures, or operations.
- Acts as a liaison between EM, QC, manufacturing, and cleaning to ensure compliance to the EM program.
- Performs as a subject matter expert during audits.
- May perform environmental monitoring sampling according to Standard Operating Procedures (SOPs) when necessary.
- Understands and utilizes EM sampling equipment and techniques as necessary (total airborne particulate, viable airborne, viable surface, and viable personnel monitoring).
- Follows cGMP and GDP to perform all tasks.
Department specific/Non-essential responsibilities:
- Develop and coach to build talent.
- Prioritizes and plans workload and team assignments to meet all internal needs for maximum efficiency and accuracy.
- Effectively trains others in a positive manner.
- Additional duties as assigned.
Experience / Skills:
- Bachelor’s degree in a scientific discipline with at least 8 years of related experience is required. Previous supervisory experience is preferred.
- Strong knowledge of cGMP is required.
- Experience in clean room environmental monitoring and aseptic technique is a required.
Competencies:
- Action oriented/drives for results.
- Excellent communication and interpersonal skills.
- Team orientation/strong team player
- Ability to coach, mentor, and teach.
- Excellent decision making, problem solving, and analytical skills.
- Detail-oriented with the ability to work under tight deadlines.
- Excellent conflict management skills.
- Builds positive relationships with others.
- Excellent time management and prioritization skills.
- Excellent technical writing skills.
- Knows the difference between managing and leading and when to apply each.
Organizational Relationship/Scope:
- Reports to QC Manager, Director of Quality.
- Work is performed without appreciable direction.
- Works with QC Manager to develop strategic objectives for the group managed.
- This position has several EM direct reports
Working Conditions:
- 75% normal office and meeting room conditions
- 25% laboratory and manufacturing environment
- Must be able to wear the appropriate personal protective equipment (PPE) necessary.
- Some off-shift and weekend work may be required.
