Analyst II, QC Aseptic Control, Lead (Night Shift - 12-Hour Rotating, 2/2/3 Schedule)
National Resilience
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.
For more information, please visit www.resilience.com
Position Summary:
This position 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.
Shift & Hours:
Night Shift - 2/2/3 Rotating Schedule
6pm - 6:30am
Position Responsibilities:
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 (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
Minimum Qualifications:
Prior experience in a pharmaceutical production or quality control role (i.e. Microbiology or Environmental Monitoring) in a GMP environment
Capable of keeping accurate records and performing mathematical calculation
Ability to effectively understand, read, write, communicate and follow instructions in the English language
Thorough attention to detail
Preferred Qualifications:
Bachelor's degree in a scientific discipline
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 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 $60,000.00 - $82,500.00 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.