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Quality Specialist I

Location Cincinnati, Ohio, United States of America Job Id R-01306229 Job Type Full time Category Quality & Regulatory Remote Fully Onsite
The Quality Difference at Thermo Fisher Scientific: What makes our quality teams unique is a shared passion for getting it done right the first time and working for the right reasons with our customers always in mind. Our team of Quality professionals understand our customers rely on the accuracy, safety, and effectiveness of our products and services that are improving lives around the world. When you join our team of quality professionals, you’ll collaborate on projects on a global scale while being encouraged to grow your skills and discover new career paths with us.
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JOB DESCRIPTION

Work Schedule

Second Shift (Afternoons)

Environmental Conditions

Office

Job Description

  • Provide Quality expertise and oversight of the batch disposition process which includes assessments of documentation to assure quality and compliance by site procedures and cGMPs.
  • Responsible for assembling and or review of batch release documentation packages (BPR/LPR/COA/COC).
  • Daily interaction with business management, planning, and technical services associates to assist with troubleshooting, documentation corrections/notes, and mentorship.
  • Aids in identification of continuous improvement opportunities; Participates in practical process improvement initiatives.

Education

Minimum requirement High School Diploma, preferably an Associates/Bachelor’s Degree in, Science, or applicable field.

Experience

Minimum 2 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

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

Knowledge, Skills, Abilities

Knowledge of FDA/EMA regulatory requirements applicable to biologics or pharmaceuticals.

Knowledge of Quality oversight of batch disposition.

Excellent organizational skills and analytical and problem-solving abilities.

Strong verbal and writing skills

Possesses exceptional time management and multi-tasking abilities to meet commitments.

accessibility disability access
Accessibility/Disability Access
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
 
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eeo and affirmative action statement
EEO & Affirmative Action Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.
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