Supervisor Environmental Monitoring

Supervisory Role

The Supervisor of Environmental Monitoring oversees a pharmaceutical quality control unit, ensuring all activities comply with Good Manufacturing Practices (GMP) and regulatory requirements. This includes overseeing multi-shift laboratories, approving testing methods, and maintaining compliance with various regulatory bodies.

Essential Functions

• Supervise multi-shift laboratories ensuring product quality meets standards and regulatory requirements.
• Maintain operational compliance with US and international regulatory agencies and guidelines.
• Ensure all necessary testing is carried out and approve specifications, sampling instructions, test methods, and procedures.
• Monitor contract testing laboratories for compliance and test results.
• Ensure appropriate validations/qualifications are completed and approved.
• Evaluate and sign laboratory records before sending them to the QA department.
• Foster team ownership and ensure compliance with all policies, procedures, and site/company regulations.
• Set clear vision by aligning goals and objectives with site strategies and managing performance management.
• Lead efforts and ideas to completion, exhibit accountability and responsibility for an area or process.
• Provide high-level internal and external customer service, challenging established procedures and systems diplomatically.
• Understand and educate team members on the business and financial impacts of decisions/actions.
• Ensure direct reports meet their quarterly ALARA goals and maintain proper safety procedures.
• Ensure proper maintenance and cleanliness of the department, premises, and equipment.
• Measure and communicate team's progress against individual, team, and site goals and Key Performance Indicators (KPI’s).
• Maintain an acceptable level of 5S in the area and promote an organized workspace.
• Lead and support all investigations, review and approve quality and safety exception reports, and ensure on-time completion of investigations and corrective action items.
• Identify opportunities to reduce risk, reduce costs of poor quality, and improve service.

Requirements

• Bachelor's Degree in Chemistry, Science, or related field required, or equivalent work experience.
• At least 10 years of relevant experience, with at least 2 years of supervisory experience.
• Strong knowledge of cGMP requirements, laboratory equipment/product validation, and regulatory guidelines (FDA, HC, TGA, EU, ISO, USP, etc.).
• Expertise in finished product manufacture, analytical analysis techniques, and statistical quality control.
• Working knowledge of Quality systems and ability to use relevant software packages to process and analyze data.

Background

• Experience in analytical method validation work.
• Thorough understanding of Quality systems.
• Ability to use relevant software packages to process and analyze data.

Material Handling

• Willingness to lift up to 70 pounds, kneel, crouch, twist the upper body, walk, bend, stoop, push, pull, reach, negotiate stairs and evacuation ladders, wear and operate safety equipment, enter vessels, and inspect equipment.

Physical Demands

• Must be able to work indoors and outdoors with exposure to mechanical/moving parts, hazards including corrosive, flammable, and toxic material, dust, dirt, odors, and irritants.
• May be required to sit or stand for long periods of 8+ hours a day while performing duties.
• Must possess good hand-eye coordination and close attention to detail.
• Willingness to complete safety training within allotted timeframes and work in a team-based environment.
• Must be able to work outside of regular work hours, including off shift, weekend, and holiday work as business needs require.

Work Environment

• Plant producing radioactive materials.
• Exposure to mechanical/moving parts, hazards including corrosive, flammable, and toxic material, dust, dirt, odors, and irritants.
• May be required to sit or stand for long periods of 8+ hours a day while performing duties.
• Must possess good hand-eye coordination and close attention to detail.
• Exposure to a team-based environment and willingness to work outside of regular work hours.