Quality Specialist III - QOTF at Thermo Fisher Scientific in Cincinnati, Ohio

Posted in Other about 23 hours ago.





Job Description:

Work Schedule

Standard (Mon-Fri)



Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Loud Noises (Equipment/Machinery), Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Standing for full shift, Will work with hazardous/toxic materials



Job Description




Essential Functions





  • In-Process Inspections: Regularly observing processes at different stages of production against established quality standards and parameters.

  • Defect identification, reporting, and resolution: Identifying any non-conforming processes or defects, reporting issues to all relevant individuals and Management, and resolving "quick-fix" issues as necessary.



  • Data collection and analysis: Document observations and analyze trends in non-forming processes to allow for proactive improvement.

  • Documentation Review: Inspect in-process documentation and spot check to proactively identify issues that may result in quality events. Stop, notify, and coach all involved individuals.

  • Communication and collaboration: Working closely with operators, supervisors, and quality engineers to perform trainings and awareness sessions/huddles around commonly-identified gaps.


Education





  • Bachelor's Degree, preferably in Science or Engineering, or related field preferred

  • Equivalent combinations of education, training, and relevant work experience may be considered.


Experience





  • Minimum 4 years' experience in QC, QA, Analytical Development, Process Engineering, Engineering services or OSD Manufacturing

  • Experience in cGMP or pharmaceutical, medical device, or related manufacturing industry


Knowledge, Skill, and Requirements





  • Strong attention to detail and ability to identify defects

  • Knowledge of quality control methodologies and standards

  • Understanding of manufacturing processes (preferably pharmaceutical)

  • Excellent communication and problem-solving skills

  • Proven ability to work collaboratively with diverse teams

  • Ability to influence across various different departments and levels


What We Offer:





  • Competitive salary based on experience.


  • Annual performance-based bonus and merit increase.


  • Comprehensive benefits package effective Day 1, including medical, dental, and vision.


  • Paid Time Off (120 hours per year) plus designated paid holidays.


  • 401K with company match up to 6%.


  • Tuition reimbursement after 90 days.


  • Employee referral bonus.



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