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Form of workJob Description
Position: QA/QC Specialist
Location: Winchester, KY, USA
Work Environment: Onsite with availability for irregular shifts
Position Overview:
Join our cutting-edge facility as a QA/QC Specialist, playing a pivotal entry-level role. This position demands the application of manufacturing and laboratory expertise, involving hands-on lab work, computer operations, and meticulous record-keeping. Focus on quality analysis and testing in a cleanroom environment adhering to cGMPs and SOPs.
Experience and Education:
- Associate Degree or Bachelor's in Science with 2 years in Laboratory and Manufacturing cleanroom environments.
- Proficiency in Microsoft Excel and Word.
- Strong attention to detail.
- Familiarity with Good Manufacturing Practices (cGMPs).
- Ability to apply basic scientific and regulatory principles.
- LIMS or MODA experience is a plus.
- Availability for off-hours or weekend work.
Key Responsibilities:
- Test utilities such as USP water, clean steam, and other manufacturing environments.
- Support the QC department following the procedures.
- Utilize MODA for data entry, compilation, and environmental trend analysis.
- Collaborate with Manufacturing and QA for routine EM, changeover EM, and monitoring.
- Perform media fills and fill/finish monitoring for air quality and aseptic techniques.
- Act as QC authority for aseptic flow and behavior within cleanrooms.
- Maintain flexibility to meet unique campaign requirements, including off-hour and weekend work.
- Maintain accurate written records of all analyses performed.
- Accurately interpret and effectively communicate analytical results and issues.
- Schedule daily tasks in an organized and efficient manner.
- Demonstrate general knowledge of the use and operation of basic laboratory equipment.
- Calibrate and maintain lab equipment and instrumentation.
- Operate in a safe manner, familiar with basic laboratory and chemical hygiene practices.
- Work seamlessly in a team environment, contributing to a "flow to the work" approach.
- Collaborate with other lab personnel to maintain a clean and safe work environment.
- Perform peer review of analytical testing and contribute to report writing.
- Write SOPs on an as-needed basis.
Join us and contribute to the excellence of our operations! Apply now to be part of a team dedicated to maintaining high standards in quality control and manufacturing. #QAQCSpecialist #QualityControl #ScienceCareers
