Quality Technician II, Aseptic Control

6 days ago

Hamilton, United States RESILIENCE US INC Full time

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: The Quality Technician II, Aseptic Control autonomously performs tasks related to environmental monitoring to support regulatory requirements of a sterile manufacturing site. This position requires operating equipment in various classified/non-classified areas up to a Class 100 aseptic environment and in a laboratory setting. This is a 12-hour rotating shift (2/2/3) - Day Shift Position Responsibilities: Prepare documentation of activities, actions, and results. Ensure proper documentation practices during job activities. Read SOPs (Standard Operating Procedures) and excerpts from technical documentation Maintain accurate and complete records (i.e., laboratory notebooks, quality records, and sample receipts) Complete required training Perform visual inspections Use the Environmental Monitoring System to collect and analyze samples Guide others on SOPs (Standard Operating Procedures), control documents, and/or other work instructions. Coordinate activities of support groups Ensure that others carry out laboratory duties in a manner consistent with cGMP Perform regular audits of SOPs (Standard Operating Procedures), and/or work instructions Perform routine sampling activities and associated data entry Wear gowning, sterile garments, and PPE (Personal Protective Equipment) as required by specific activities Read and interpret diagrams, drawings, and other schematics Recommend and initiate activities to ensure area and equipment are maintained in a state of compliance Provide 24/7 "on-call" support to others Provide feedback on service and quality issues on a timely basis Minimum Qualifications: Prior experience in a pharmaceutical production environment Must have the ability to effectively understand, read, write, communicate, and follow instructions in the English language Thorough attention to detail is required Must be capable of keeping accurate records and performing mathematical calculations Preferred Qualifications: High school graduate, vocational school graduate, or equivalent Working knowledge of MODA, Microsoft applications, SAP, KRONOS Experience working in a LEAN manufacturing environment Knowledge of cGMPs and FDA policies/procedures The items described here are representative of those that must be met successfully to perform the essential functions of this job. 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

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