Supervisor - QC Environmental Monitoring Night Shift

Role Summary

Supervisor - QC Environmental Monitoring Night Shift. Oversight and supervision of the QC Environmental Monitoring Technicians, coordinating environmental monitoring activities for Parenteral Operations and routine facility monitoring, and assisting in training and providing alternate support as required.

Responsibilities

• Ensure and enforce compliance with all cGMP procedures, Quality Systems, and Good Documentation Practices.
• Provide supervision and oversight of the QC Environmental Monitoring Technicians during day-to-day activities and non-routine tasks as needed.
• Coordinate environmental monitoring activities and assign responsibilities to technicians.
• Perform technical training and mentor technicians through formal processes/programs.
• Provide alternate support in routine or non-routine environmental monitoring activities as required.
• Provide shift support for technicians during non-routine events and escalate to management as required.
• Author and review Standard Operating Procedures, Work Instructions/Tools, and assist with Development of Training Plans.
• Facilitate development for direct reports, including coaching/mentoring, goal setting, and performance feedback.
• Comply with and assist in implementing safety standards.

Qualifications

• Associate degree or equivalent.

Additional Preferences

• 4+ years of relevant experience in performing Environmental Monitoring in a GMP Pharmaceutical Manufacturing facility, preferably with aseptic production.
• Proficiency in environmental monitoring techniques (viable surface, viable and non-viable air, compressed air, water collection and analysis).
• Experience with Laboratory IT systems (LIMS, LES, MODA).
• Strong understanding of cGMP requirements and regulatory guidance for a GMP pharmaceutical facility.
• Interpersonal skills with teaching/coaching experience; strong oral and written communication.
• Continuous improvement mindset.
• Ability to work in a lab environment with PPE and cleanroom attire as required.
• Bachelor’s degree in a science-related field preferred.

Skills

• Leadership and supervision
• Environmental monitoring techniques
• Training and development
• Documentation and SOP/WI development
• Communication and collaboration

Education

• Associate degree or equivalent; Bachelor’s degree in science preferred.

Additional Requirements

• Ability to work 12-hour night shifts; flexible schedule during project phase for training or transition.
• Physical requirements: tasks may involve repetitive motion, standing/walking for long periods, and lifting up to 30 pounds; may involve manual handling and PPE usage.
• Travel during the project phase for training and implementation of the Environmental Monitoring Program at the Concord site.