Quality Specialist I - Records
Quality Specialist I - Records
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Salary Not Disclosed
1 Vacancy
Job Description
Work Schedule
Standard (MonFri)Environmental Conditions
OfficeJob Description
Job Description
As part of the Thermo Fisher Scientific team youll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the worlds toughest challenges like protecting the environment making sure our food is safe or helping find cures for cancer.
Location/Division Specific Information
Cincinnati OH
Hours: 9:00am 5:00pm Monday Friday
Discover Impactful Work:
The QA Specialist will perform activities in support of disposition of product while ensuring compliance with Thermo Fisher directives and procedures customer requirements and regulatory standards. Performs Quality batch record and documentation review. Works with manufacturing and crossfunctional team members to ensure customer expectations are met to support release.
A day in the Life:
- 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 guidance.
- Aids in identification of continuous improvement opportunities; Participates in practical process improvement initiatives.
Keys to Success:
Education
- Minimum requirement High School Diploma preferably an Associates/Bachelors 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 relevant 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 problemsolving abilities
- Strong verbal and writing skills
- Possesses exceptional time management and multitasking abilities to meet commitments and deadlines.
Required Experience:
Unclear Seniority
Employment Type
Full-Time
