Vacancy caducado!
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.
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Position Summary:
TheSupervisor, Quality Control Aseptic 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 analysts working a 24/7 shift pattern.
The Supervisor, Quality Control Aseptic must be willing to work a flexible schedule that allows oversight of all production shifts. As a responsible leader for the operation, this must be done while maintaining effective employee relations and compliance to cGMP, other regulatory, and SOX requirements, as well as SHE obligations and Resilience standards.
As a member of QC leadership, the Supervisor, Quality Control Aseptic will also be responsible for delivering site Quality priorities and initiatives as appropriate.
Note: This is a Day Shift position (12-hour rotating schedule)
Job Responsibilities:
Develop and maintain a high performing team of Aseptic Control Team Leads and Technicians
Trained and able to perform all Environmental Monitoring (EM) technician responsibilities (including maintaining aseptic qualification) when needed.
Accountable for the completion of Monthly and annual trending, EMPQs and related document updates, deviations and investigations related to environmental monitoring process, and the review and approval of completed production and laboratory documentation (for example: 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 as assigned.
Minimum Qualifications:
Significant experience in production or quality control environment.
Working knowledge of Microsoft applications and other computerized systems
Knowledge of cGMPs and global regulatory policies/procedures
Basic knowledge of physical, chemical, and microbiological tests in Quality Control
Basic knowledge of sterile room techniques, chemical handling and usage
Ability to schedule and direct the work of others
Ability to work effectively in a team environment
Candidate should possess the ability to work in a changing/demanding environment
Strong communication and leadership skills.
Problem solving skills.
Preferred Qualifications:
Bachelor of Science in Engineering, Pharmacy, related Science or business.
Experience working in a LEAN manufacturing environment
Working knowledge of LDMS or Veeva, Microsoft applications, SAP, Trackwise
Training or experience in environmental monitoring, microbiology, quality control, validation, technology transfer, change control.
Knowledge or previous experience in managing technical programs/projects
Strong mechanical, troubleshooting and problem-solving abilities.
Ability to direct and participate in cros
Vacancy caducado!