Batch Record Reviewer
Thermo Fisher Scientific

Work Schedule
First Shift (Days)

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, Cold Room/Freezers -22degreesF/-6degrees C, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

When you're part of the team at Thermo Fisher Scientific, you'll do important work. And you'll have the opportunity for continual growth and learning in a culture that empowers your development. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.

Location/Division Specific Information

CTD partners with pharmaceutical and biotech customers around the world to ensure the right patients get the right therapies in the right doses at the right time - a concept that we internally embrace as "There is a Patient Waiting." Our unique blend of services includes project management, packaging, distribution, transportation management and specialty logistics, ancillary supply management, clinical supply optimization, bio-repository storage and much more. Our more than 3000 employees in over 15 countries work hard every day knowing that what they do matters.)

Discover Impactful Work:

As part of our global team, what you do contributes directly to our mission; enabling our customers to make the world healthier, cleaner and safer.

A day in the Life:

• Independently reviews performed batch records, labels, specifications, and other manufacturing documents for drug products, drug substance, medical device, and combination products under clinical development in compliance with FCS Standard Operating Procedures (SOPs), US FDA GMPs, ICH and international health agency requirements, as appropriate.
• Functions as a batch reviewer to verify performed manufacturing batch records, analytical data, test records, stability data, certificate of analysis, certificate of testing, environmental reports, and associated documentation, including any deviations, complaints, investigation reports, and change control related to material disposition.
• Ensures that all results are within specification and performed per the applicable SOPs, Client Requirements and test methods and that appropriate GMPs were followed.

Keys to Success:

Education

• High school diploma or equivalent required.

Experience

• A minimum of 1 year in the pharmaceutical/related regulated industry.
• One (1) year of working Operations pharmaceutical experience in a GMP environment, preferably in Quality.
• Experience in the review of batch record content, inspection, and test records preferred

Knowledge, Skills, Abilities

• Working knowledge and understanding of cGMP related requirements and proficiency of the FDA, and MHRA regulatory and ICH guidelines.

Physical Requirements / Work Environment

• This position requires standing, bending, reaching, walking and talking as well as exerting up to 20 pounds.

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer a company culture that stands for integrity, intensity, involvement, and innovation!

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