Analyst II, QC Aseptic Control, Lead (Night Shift)

About the role

The Analyst II, QC Aseptic Control, Lead autonomously performs tasks related to environmental monitoring to support regulatory requirements of a sterile manufacturing site. This includes operating equipment in various classified/non-classified areas up to a Grade A aseptic environment and in a laboratory setting, and maintaining gowning qualification.

Responsibilities

• Schedule work and load the correct pulls in Environmental Monitoring System
• Troubleshoot methods and processes
• Develop methods and processes
• Serve as the primary link between QC team and Operations for day-to-day activities, such as schedules and workload planning
• Coordinate workflow in Environmental Monitoring team
• Verify QC data while monitoring for trends and abnormalities
• Maintain training to perform all Environmental Monitoring technician responsibilities (including maintaining aseptic qualification) when needed
• Review completed production documentation (e.g., logbooks) for quality, completeness, and cGMP (Good Manufacturing Practices) compliance
• Assign work tasks and activities to others
• Perform logbook reviews
• Train others on systems, software, equipment, machines, procedures, and/or processes
• Answer compliance and process questions from others
• Communicate policies and procedures to employees
• Fill in for immediate supervisor when needed
• Gather, organize, and communicate operational information to others
• Lead and coordinate investigations and studies with little supervision
• 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
• Monitor training of employees to ensure compliance
• Perform other duties that support Environmental Monitoring, Operations, or Laboratory Processes

Requirements

• Prior experience in a pharmaceutical production or quality control environment
• Ability to effectively understand, read, write, communicate, and follow instructions in the English language
• Thorough attention to detail because individual must be capable of keeping accurate records and performing mathematical calculations

Qualifications

• Bachelor’s degree in scientific discipline (preferred)
• Prior experience in a sterile or cGxP environment (preferred)

Schedule

Night Shift: 6pm - 6:30am
2/2/3 Schedule (12-Hour Rotating)

Pay

Target base pay hiring range for this position is $60,000.00 - $86,250.00 per year. Actual base pay is dependent upon factors including, but not limited to, geographical location, relevant experience, qualifications, skills, and knowledge.

Benefits

Resilience offers employees a robust total rewards program including:

• 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, and other paid leaves of absence
• Tuition reimbursement
• Support for caregiving needs