Supervisor, Quality Control Aseptic (Day Shift)

Resilience•West Chester, OH

21h•Onsite

About The Position

The Supervisor, Quality Aseptic Control is responsible for execution of the environmental monitoring and aseptic control activities in accordance with the site operating strategy and the aseptic strategy. This includes leading a high performing team of leads and technicians working a 24/7 shift pattern; therefore, they must be willing to work a flexible schedule that allows oversight of all production shifts. As a responsible leader for the operation, the role includes maintaining effective employee relations and compliance to cGMP, other regulatory, and SOX requirements, as well as EHS obligations and Resilience standards. As a member of QC leadership, the individual will also be responsible for delivering QC and site Quality priorities and initiatives, as appropriate.

Requirements

Strong communication and leadership skills
Problem solving skills
Training or experience in environmental monitoring, microbiology, quality control, validation, technology transfer, or change control
Knowledge or previous experience in managing technical programs/projects
Strong mechanical, troubleshooting, and problem-solving abilities
Ability to direct and participate in cross-functional teams
Project management skills
Experience in production or quality control environment

Nice To Haves

Bachelor’s degree in engineering, pharmacy, or a related science or business
Experience working in a LEAN manufacturing environment
Working knowledge of LDMS or Veeva, Microsoft applications, SAP

Responsibilities

Develop and maintain a high performing team of Aseptic Control Team Leads and Technicians
Trained and able to perform all EM technician responsibilities (including maintaining aseptic qualification) when needed
Accountable for the completion of: Monthly and annual trending
Accountable for the completion of: EMPQ and related document updates
Accountable for the completion of: Deviations and investigations related to environmental monitoring process or results
Review completed production and laboratory documentation (i.e., log books) for quality, completeness, and cGMP (Good Manufacturing Practices) compliance
Train others on procedures and/or processes
Answer compliance and process questions from others, including regulatory agencies
Communicate policies and procedures to employees
Gather, organize, and communicate operational information to others
Lead process improvement activities and teams to meet strategic goals
Communicate priorities and progress to team on a continuing basis
Ensure that employees have the tools needed to perform their jobs safely
Monitor training of employees to ensure compliance
Other duties that support Environmental Monitoring, Operations, or Laboratory processes may be assigned.