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Analyst II, QC Aseptic Control, Lead (Night Shift - 12-Hour Rotating, 2/2/3 Sche Job in Hamilton, Ohio US

Analyst II, QC Aseptic Control, Lead (Night Shift - 12-Hour Rotating, 2/2/3 Sche

RESILIENCE US INC - Hamilton, OH

Posted: 3/16/2025 - Expires: 6/14/2025

Job ID: 286664823

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Job Description

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.

RESILIENCE (National Resilience, Inc.), is an equal opportunity employer. Employment decisions are made without regard to race, color, religion, national origin, gender, sexual orientation, gender identity, age, physical or mental disability, genetic factors, or military/veteran status or any other characteristics protected by law. EEO Minorities/Women/Disabled/Veterans

Job Summary

Employment Type:
Full Time Employee
Job type:
Federal Contractor
Skill Based Partner:
No
Education Level:
No school grade completed
Work Days:
Mon, Tue, Wed, Thu, Fri
Job Reference Code
82997198
Salary
N/A
Licenses / Certifications:
N/A
Display Recommended WorkKeys®Recommended WorkKeys®:
Applied Math: 6
Graphic Literacy: 6

Workplace Documentation: 5