Supervisor, Quality Control Aseptic

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

Other duties that support Environmental Monitoring, Operations, or Laboratory processes may be assigned.

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

Pay

The target base pay hiring range for this position is $75,000.00 - $116,250.00 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.