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

A career at Resilience is more than just a job - its an opportunity to change the future.
Resilience is a technology-focused biomanufacturing company thats changing the way medicine is made. Were 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.
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Job Summary
The Analyst II, QC Aseptic Control, Leadautonomously 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.
Job 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
Hours (Night Shift):
6pm - 6:30am
2/2/3 Schedule (12-Hour Rotating)
Minimum 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 calculation
Preferred Background
Bachelors degree in scientific discipline
Prior experience in a sterile or cGxP environment
The work schedule listed reflects the employees expected schedule at the time of hire. The Company reserves the right to modify work schedules at any time, with or without notice, based on business needs, operational requirements, or other considerations.
Sponsorship or support for work authorization, including visas, is not available for this position.
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 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, paid vacation, 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 - $86,250.00 per year. Actual base pay is dependent upon a number of factors, including but not limited to, the candidates geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience? We encourage you to apply and start a conversation with one of our recruiters.