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Quality Technician II, Aseptic Control

2 weeks ago


Butler County, United States National Resilience 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. Job SummaryThe Quality Technician II, Aseptic Control (Night Shift) is responsible for autonomously performing tasks related to environmental monitoring to support regulatory requirements of a sterile manufacturing site.**This a Night Shift position working 6pm - 6:30am. 2 days on, 2 days off, 3 days on, 3 days off and the rotation starts over again. Job ResponsibilitiesPrepare documentation of activities, actions, and results. Ensure proper documentation practices during job activities. Read SOPs (Standard Operating Procedures) and excerpts, from technical documentationMaintain accurate and complete records (i.e., laboratory notebooks, quality records, and sample receipts)Complete required trainingPerform visual inspectionsUse the Environmental Monitoring System to collect and analyze samplesGuide others on SOPs, control documents, and/or other work instructions. Coordinate activities of support groupsEnsure that others carry out laboratory duties in a manner consistent with cGMPPerform regular audits of SOPs and/or work instructionsPerform routine sampling activities and associated data entryWearing gowning, sterile garments, and PPE (Personal Protective Equipment) as required by specific activitiesRead and interpret diagrams, drawings, and other schematicsRecommend and initiate activities to ensure area and equipment is maintained in a state of complianceProvide 24/7 "on-call" support to othersProvide feedback on service and issues on a timely basisMinimum Qualifications:Prior experience in a pharmaceutical production environmentMust have the ability to effectively understand, read, write, communicate, and follow instructions in the English languageThorough attention to detail is requiredMust be capable of keeping accurate records and performing mathematical calculationsPreferred Qualifications:High school graduate, vocational school graduate, or equivalentWorking knowledge of MODA, Microsoft applications, SAP, KRONOSExperience working in a LEAN manufacturing environmentKnowledge of cGMPs and FDA policies/proceduresThe 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 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 $21.50 - $30.50 per hour. 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.