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.
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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 cross-functional teams.
Project management skills.
The items described here are representative of those that must be met successfully to perform the essential functions of this job.
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.
Resilience offers employees a robust total rewards program including equity, 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, flexible time off, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs. Our target base pay hiring range for this position is $75,000.00 - $112,500.00 per year. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate's geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience and the biomanufacturing revolution? We encourage you to apply and start a conversation with one of our recruiters.