
Analyst II, Quality Control (Night Shift)
Fairfield, OHJobSeen todaySeen in employer's feed today
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Job overview
The Analyst II, Quality Control performs on-the-floor sampling, testing, data review, and documentation in a cGMP manufacturing and laboratory environment. The role handles finished products, raw materials, stability, in-process materials, and water samples; supports investigations, method and SOP updates, and development and validation activities; and may perform environmental monitoring. Work includes cleanroom activities and a rotating 12-hour night shift.
Skills & qualifications
Skills
Qualifications
Full 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 Brief Job Description The position involves on-the-floor sampling, data review, and documentation in compliance with cGMP standards. The individual will conduct testing on a variety of samples, including finished products, raw materials, stability, in-process materials, and water systems. Strong attention to detail, adherence to quality standards, and the ability to work autonomously in a regulated environment are essential. Job Responsibilities Core Responsibilities - Performs testing on a range of samples including finished products, raw materials, stability, in-process and water samples. - Maintains and troubleshoots testing equipment. - Supports laboratory investigations, QC method and SOP updates. - Executes laboratory test protocols to support development and validation activities. - Responsible for QC data review. - Provides and follows up on ideas for continuous improvements in laboratory processes. - Able to take direction and correction when learning procedures and performing analysis. - Participates in and contributes to the team atmosphere. - Self-motivated: able to complete all tasks assigned and able to self-assign work without immediate supervision, when appropriate. - Able to knowledgeably and safely handle hazardous materials. - Good verbal, written and interpersonal communication and organizational skills. - The ability to learn and adapt quickly to new priorities and/or situations. - This position may require operating equipment in various classified/non-classified areas up to a Class 100 aseptic environment and in a laboratory setting. - This role may require collaboration and communication within the team and with operations groups/QA. - The role may require individuals to autonomously perform tasks related to environmental monitoring to support regulatory requirements of a sterile manufacturing site, including data review and on-the-floor sampling. Experience & Education Minimum Qualifications - Working knowledge of cGXP requirements and a strong familiarity with production operations. - Good problem-solving skills. - Proficient in math, laboratory and computer skills. Understands basic statistics and quality control terminology. Preferred Qualifications - Bachelor's degree in chemistry, biology or a related field. - QC chemistry laboratory experience in the pharmaceutical industry. - Working knowledge of laboratory equipment (including HPLC), operations, and safety. Physical & Work Environment - Work is performed onsite in a cGMP manufacturing and laboratory environment, including cleanrooms classified up to Class 100 (ISO 5) aseptic areas. - Requires gowning and adherence to aseptic behavior requirements for the duration of cleanroom activities. - Requires standing, walking, bending and reaching for extended periods, and the ability to lift up to 25 pounds. - Requires the ability to work a rotating 12-hour night shift, including weekends and holidays as scheduled. Work Schedule: Night Shift - 6pm - 630am with a 12-hour rotation on a 2 nigh
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