Quality Specialist I - Records - 2nd Shift

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

As 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.

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 mentorship.
Aids in identification of continuous improvement opportunities; Participates in practical process improvement initiatives.

Education

High School Diploma or equivalent
Associates/Bachelor’s Degree in, Science, or applicable field, preferred.

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.