Supervisor, Quality Control Aseptic (Day Shift)

Resilience•West Chester, OH

21h•$75,000 - $116,250•Onsite

About The Position

A career at Resilience is more than just a job – it’s an opportunity to change the future. Resilience is a technology-focused biomanufacturing company that’s changing the way medicine is made. We’re building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need. For more information, please visit www.resilience.com The Supervisor, Quality Aseptic Control (Day Shift) 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. RESILIENCE is a first-of-its-kind manufacturing and technology company dedicated to broadening access to complex medicines and protecting biopharmaceutical supply chains against disruption. Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions to ensure the medicines of today and tomorrow can be made quickly, safely, and at scale. RESILIENCE will offer the highest quality and regulatory capabilities, and flexible and adaptive facilities to serve partners of all sizes. By continuously advancing the science of biopharmaceutical manufacturing and development, RESILIENCE frees partners to focus on the discoveries that improve patients’ lives.

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 EMPQ and related document updates 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.