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Analyst II, Quality Control (Night Shift)

RESILIENCE US INC

Fairfield, OHJobSeen todaySeen in employer's feed today

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At a glance

Compensation
No compensation found
Location
Fairfield, OH
Work Authorization
Not specified

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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

RequiredNice to have

Skills

Attention to DetailcGXP RequirementsProduction OperationsProblem SolvingMathLaboratory SkillsComputer SkillsBasic StatisticsQuality Control TerminologyQC ChemistryPharmaceutical IndustryLaboratory EquipmentHPLCLaboratory OperationsLaboratory SafetyStandingWalkingBendingReachingLifting 25 Pounds

Qualifications

Bachelor's in Chemistry, Biology or Related Field

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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