Back to Jobs search

R&D/Mfg Scientist II-Reviewer

ThermoFisher Scientific • Greenville, NC • 1d ago

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Laboratory Setting

Job Description

The R&D Scientist II-Reviewer independently performs complex data reviews in support of validations, development testing, protocols and reports. In addition, the reviewer is to provide necessary support of in-process, release and stability testing. The reviewer functions are also dedicated to laboratory Integrity Compliance activities as mandated by corporate standards.

Key Responsibilities:

Perform cGMP analytical data review for various techniques to ensure adherence to established procedures, analytical standards, GVLs and SOPs

Determine if reported data meets specification or expected standards

Verify that data is correctly entered into its designated software systems for approval (LIMS/SLIM)

Trend data where applicable to ensure requirements are met

Ensure that all laboratory testing and activities are carried out in compliance with regulations, ICH guidelines, and USP/EP Pharmacopeia, GMP and data integrity requirements

Assist in trainings as an SME

Communicate with Project Lead/Managment concerning project status and/or concerns

Demonstrate ability to work as a team player and in a fast-paced environment

Must be able to set project priorities and time management in order to maximize productivity

Actively participate in ongoing trainings and seek out opportunities to increase contributions for development of skills and responsibilities

Work closely with analyst to complete corrections

Might Author and/or review: OOS investigations, Deviations and Change Controls, CAPA, technical reports, Protocols and validation summaries , SOPs

Ensure all job-related safety training and compliance requirements are met

Qualifications:

Associates degree required -bachelor's degree preferred) All degrees must be from a scientific discipline or

Associates degree with 5 years of pharmaceutical experience and 3 or more years of reviewing data for cGMP compliance or

Bachelor's degree with 3-5 years of pharmaceutical experience and 2 or more years of reviewing data for cGMP compliance

Advanced knowledge and experience in Empower

Advanced knowledge in HPLC, UV, FT-IR, UV, Karl Fischer Titration, IEF (Preferred), ELISA (Preferred), CGE (Preferred), Dot-Blot (Preferred)

Demonstrate knowledge in method validation

Experience with analytical method development, validation, transfer, and verification for drug products and raw materials is advantageous

Experience testing for assay, impurities, content uniformity, potency

Data trending and interpretation of analytical results

Strong knowledge of GMP, GLP regulatory requirements

Strong organizational, communication, and leadership skills

Ability to manage multiple priorities and meet deadlines

Proficiency in Microsoft Office applications

Demonstrated ability to work independently and collaboratively

Fluent in English

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.

Similar Jobs

Teller Retail Banker

Woodforest National Bank • Tarboro, NC • 5h ago

Retail & Hospitality

Take the next step toward your new career today! Become a part of the diverse and inclusive team within our nationally recognized award-winning Bank that is one of the strongest in the nation.Woodforest National Bank is...

5h ago

Go to Apply

North America Regional Product Manager (Protein Diagnostics)

ThermoFisher Scientific • Greenville, NC • 23h ago

Hospital & Medical

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Regional Product Manager, North America Position Summary & Scope The Regional Product Manager, North America is responsible for driving...

23h ago

Go to Apply

Senior Medical Writer

ThermoFisher Scientific • Greenville, NC • 1d ago

Hospital & Medical

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description ?Join Us as a Senior Medical Writer - Make an Impact at the Forefront of Innovation Provides high-quality medical and scientific writing fr...

1d ago

Go to Apply

Director, Learning & Customer Excellence

ThermoFisher Scientific • Greenville, NC • 1d ago

Management & Administrative

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description This is a fully remote role supporting our Global Central Laboratories. We welcome applicants from all locations within the US. Must be leg...

1d ago

Go to Apply

Case Picker

Ryder System • Tarboro, NC • 2d ago

Position Description Ryder is hiring Case Pickers in Tarboro, NC - offering weekly pay, excellent benefits, and a career you can feel good about. Warehouse Positions Pay Weekly Hourly Pay $19.50 per hour Additional Pay:...

2d ago

Go to Apply

Warehouse Shipping and Receiving

Ryder System • Tarboro, NC • 2d ago

Manufacturing & Warehouse

Position Description Ryder is hiring Shipping & Receiving Clerks in Tarboro, NC - offering weekly pay, excellent benefits, and a career you can feel good about. Warehouse Positions Pay Weekly Hourly Pay $22.00 per ho...

2d ago

Go to Apply

Warehouse Part Time Overnight

Lowe's • Winterville, NC • 2d ago

Manufacturing & Warehouse

Your Impact at Lowe's As a Receiver/Stocker, you help keep the store clean, safe, and ready for customers by accurately receiving freight, stocking shelves, and organizing merchandise and top stock. You'll unload deliver...

2d ago

Go to Apply

Warehouse Material Handler

Ryder System • Tarboro, NC • 2d ago

Manufacturing & Warehouse

Position Description Ryder is hiring Material Handlers in Tarboro, NC - offering weekly pay, excellent benefits, and a career you can feel good about. Warehouse Positions Pay Weekly Hourly Pay $20.50 per hour Additional...

2d ago

Go to Apply

Warehouse Manager (2nd Shift)

Ryder System • Tarboro, NC • 2d ago

Retail & Hospitality

Job Seekers can review the Job Applicant Privacy Policy by clicking here ( http://ryder.com/job-applicant-privacy-policy ) . Job Description : Job Description Shift schedule: Monday - Friday from 3:00 pm to 11:00 pm with...

2d ago

Go to Apply

Warehouse Manager (1st Shift)

Ryder System • Tarboro, NC • 2d ago

Retail & Hospitality

2d ago

Go to Apply

Subscribe to get new jobs sent directly to you
(no charge, cancel anytime)