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

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.

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


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

• 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

• 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

• 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.