Quality Control Chemist

Redbock - an NES Fircroft company provided pay range

This range is provided by Redbock - an NES Fircroft company. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

$45.00/hr – $55.00/hr

Direct message the job poster from Redbock - an NES Fircroft company

The QC Chemists will play a key role in executing and reporting analytical/chemistry test methods for raw materials, drug substance and drug product for large molecule clinical and commercial products.

• Performs implementation and execution of routine and ad hoc chemical and analytical testing for raw materials and large molecule drug substance and drug product
• Supports the qualification and implementation of USP/EP methods and product specific methods as part of new product introduction and technology transfer
• Supports stability testing of drug substance and drug product for all time points and conditions.
• Supports quality events such as CAPA, Change Control, Deviations, and LIR/OOS as subject matter expert for QC Chemistry
• Generates, analyzes, and reports data and takes appropriate action
• Works within Lab Ware LIMS for execution of methods, data trending and report issuance.
• Reviews documentation for product disposition, generates COA/COC and batch summary reports
• Works with accuracy, urgency and a continuous improvement perspective
• Provides flexible support for on-call or outside normal business hours if required

BS in Chemistry or related science and 4+ years in a GMP-regulated chemistry laboratory; large-molecule/biologics experience preferred.

• Strong knowledge of GMP regulations and current USP/Ph. Eur., FDA, and ISO standards/guidance.
• Able to work independently while building productive relationships with internal teams and external partners; excellent written and verbal communication.
• Track record of right-first-time execution, accuracy, and proactive problem-solving, with strong collaboration and project-management skills.
• Meets physical requirements, including specialized gowning; ability to lift and manipulate items >25 lbs, climb ladders, and stand for extended periods.
• Proficient with Master Control and Lab Ware LIMS.

Mid-Senior level

Contract

Science