- 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.
- Minimum requirement High School Diploma, preferably an Associates/Bachelor's Degree in, Science, or applicable field.
- 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 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 and deadlines.
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Quality Assurance Specialist I - Cincinnati, United States - Thermo Fisher Scientific
Description
Job DescriptionAs part of the Thermo Fisher Scientific team, you'll 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 world's 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 - Tuesday - Saturday
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 cross-functional team members to ensure customer expectations are met to support release.
A day in the Life:
Education
Apply today
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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