Supervisor, Quality Aseptic Control (Night Shift)
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 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.
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.
Benefits
- Resilience offers employees a robust total rewards program including an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, paid vacation, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
Number of Employees
501-1,000 employees
