Supervisor, Quality Control Aseptic
About The Position
The Supervisor, Quality Aseptic Control (Night Shift) is responsible for the execution of 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. 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
- Accountable for the completion of: 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
- annual cash bonus program
- 401(k) plan with a generous company match
- healthcare (including medical, dental and vision)
- family building benefits
- life and disability insurance
- paid vacation
- paid holidays
- other paid leaves of absence
- tuition reimbursement
- support for caregiving needs
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What This Job Offers
Job Type
Full-time
Career Level
Manager
