Analyst II, QC Aseptic Control, Lead; Day Shift

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.

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. In addition, the incumbent will perform tasks related to scheduling work and loads, reviewing sampling and lab data, performing project work, leading laboratory investigations, and training and coaching colleagues.

• Schedule work and load the correct pulls in Environmental Monitoring System
• Troubleshoot methods and processes
• Develop methods and processes
• May 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 (for example: logbooks) for quality, completeness, and cGMP 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

Day Shift: 6:00AM – 6:30PM. 12‑hour rotating shift schedule 2 days work, 2 days off, 3 days work.

• 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 and capability to keep accurate records and perform mathematical calculations
• Preferred:
  Bachelor’s degree in a scientific discipline
• Preferred:
  Prior experience in a sterile or cGxP environment

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 does not offer sponsorship or support for work authorization, including visas, for this position.

Resilience offers employees a robust total rewards program including an annual cash bonus program, a 401(k) plan with a generous company match, and a benefits package designed to support healthcare (medical, dental, vision), family building benefits, life and disability insurance, paid vacation, paid holidays, other paid leaves of absence, tuition reimbursement, and support for caregiving needs.

Hiring range: $60,000.00 – $86,250.00 per year. Actual base pay depends on location, experience, qualifications, skills, and knowledge.