Supervisor, Quality Aseptic Control (Night Shift)

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

Position Summary

The Supervisor, Quality Aseptic Control (Night 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.

Job 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.

This is a night shift position

• 6 PM-6:30 AM

• 2 days on, 2 days off, 3 days on, 3 days off and the rotation starts over

Minimum Qualifications

• 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

Preferred Qualifications

• 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

Sponsorship or support for work authorization, including visas, is not available for this position.

Resilience is an Equal Employment Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, disability status, physical or mental disability, genetic information, or characteristic, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state, and local laws. Requests for reasonable accommodation can be made at any stage of the recruitment process.