Mid- Senior QC ScientistApply Now
Location: Bedford, Massachusetts 01730
Employment Type: Contract
Contract Length: 6 months
Job Summary: This individual will be primarily responsible for development, validation, and transfer of methods for new raw materials, intermediates, and finished products as well as the activities and procedures which are required to sample and test raw materials, work-in-process samples, finished goods, and stability samples under cGMP conditions.
- Coordinate with Tech Transfer during the scale up process to ensure testing methods are transferred and implemented in compliance with requirements of ICH Q2B and other applicable method validation guidelines.
- Validation of all new methods and method improvements in compliance with requirements of ICH Q2B and other applicable method validation guidelines.
- Collaborates with R&D to develop test methods for new products
- Performance of QC method qualification, validation and transfers as applicable.
- Writes technical reports to support regulatory submissions pertaining to method development, method validation, analytical testing results and product stability.
- Requires BS in Chemistry or other Physical Science or 7-10 years of relevant experience.
- Minimum of five (5) years in a laboratory developing, validating, and performing analytical methods.
- 5+ years testing experience in FDA regulated pharmaceuticals or medical device industries
- Demonstrated experience with GMP/ ISO regulations
- Proficient in HPLC, GC analyses, FTIR, and UV/Vis. Demonstrated experience with complex manual and automated test methods and equipment.
He's a natural people person.
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