Quality Technician II (Night Shift)
Resilience, Frankfort, KY, United States
.Quality Technician II (Night Shift) page is loaded## Quality Technician II (Night Shift)locations:
USA - OH - West Chestertime type:
Full timeposted on:
Posted Yesterdayjob requisition id:
R-106790A 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**Position Summary**This position autonomously performs tasks related to environmental monitoring to support regulatory requirements of a sterile manufacturing site. The position requires operating equipment in various classified
on-classified areas up to a Class 100 aseptic environment and in a laboratory setting. This position autonomously performs tasks related to environmental monitoring to support regulatory requirements of a sterile manufacturing site. The position requires operating equipment in various classified
on-classified areas up to a Class 100 aseptic environment and in a laboratory setting.**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 is 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**Hours (Night Shift):*** 6 PM-6 AM* 2 nights on, 2 nights off, 3 nights on, 3 nights off and the rotation starts over**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/proceduresThe work schedule listed reflects the employee’s 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. Nothing in this description creates a guarantee of specific hours, days, or shift assignments.***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.
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USA - OH - West Chestertime type:
Full timeposted on:
Posted Yesterdayjob requisition id:
R-106790A 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**Position Summary**This position autonomously performs tasks related to environmental monitoring to support regulatory requirements of a sterile manufacturing site. The position requires operating equipment in various classified
on-classified areas up to a Class 100 aseptic environment and in a laboratory setting. This position autonomously performs tasks related to environmental monitoring to support regulatory requirements of a sterile manufacturing site. The position requires operating equipment in various classified
on-classified areas up to a Class 100 aseptic environment and in a laboratory setting.**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 is 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**Hours (Night Shift):*** 6 PM-6 AM* 2 nights on, 2 nights off, 3 nights on, 3 nights off and the rotation starts over**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/proceduresThe work schedule listed reflects the employee’s 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. Nothing in this description creates a guarantee of specific hours, days, or shift assignments.***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.
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