QC Environmental Monitoring Supervisor- (Off Shift) - Relocation to Concord, NC
Lilly
- Memphis, TN
- Permanent
- Full-time
- 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 the day-to-day activities, including any non-routine day-to-day activities (i.e., Media Fills, EM PQs) that may arise based on production needs.
- Coordinate environmental monitoring activities and assign job responsibilities to QC Environmental Monitoring Technician(s).
- Perform technical training and mentor QC Environmental Monitoring Technicians through formal process/program.
- Provide alternate support in assisting with routine or non-routine environmental monitoring activities as required.
- Provide shift support for QC Environmental Monitoring Technicians when non-routine events occur and escalate to management as required.
- Author and review Standard Operating Procedures, Work Instructions/Tools, and assist with development of the QC Environmental Monitoring Technician’s Learning and Development (Training) Plans.
- Facilitate development for all direct reports, including but is not limited to coaching/mentoring of QC Environmental Monitoring Technicians, establishing goals, and providing performance improvement and performance recognition feedback.
- Comply with and assist in implementing safety standards.
- Support internal and external audits when necessary.
- Support EM investigations (excursions, nonconformance) as needed.
- Education
- Associate degree or equivalent, Bachelor’s (4-year) degree in a science related field is preferred.
- Experience
- 4+ years of demonstrated relevant experience in performing Environmental Monitoring in a GMP Pharmaceutical Manufacturing facility, preferably associated with aseptic production.
- 1-2 plus years supervisory experience preferred.
- Demonstrated proficiency in environmental monitoring techniques including, but not limited to viable surface monitoring, viable and non-viable air monitoring, compressed air monitoring, and water (potable, purified water, water for injection, clean steam) collection and analysis.
- Previous experience with Laboratory IT systems such as LIMs, LES, and MODA.
- High level of experience with cGMP requirements, compliance, and regulatory guidance associated with a cGMP Pharmaceutical Manufacturing facility.
- Possess interpersonal skills and demonstrated teaching/coaching experience.
- Possess oral and written communication skills for communicating to employees, management, and other departments.
- Ability to focus on continuous improvement.
- Ability to work in a lab environment including wearing appropriate PPE and other safety related equipment or considerations.
- Ability to gown into facility dedicated cleanroom attire, as required to perform job responsibilities.