Associate II, QC ChemistryApply Now
Location: Cambridge, Massachusetts 02139
Employment Type: Contract
Contract Length: 6+ months
Job Summary: Perform cGMP QC testing for QC Chemistry, release and stability.
- Performs routine analytical chemistry testing including HPLC, UPLC, UV, Particle Analysis and Dynamic Light Scattering
- Supports special projects as assigned
- May assist with Troubleshoots assay methods and equipment.
- Performs data entry and supports trending
- Performs general laboratory support activities including reagent preparation, sample management, equipment maintenance, lab housekeeping etc.
- Supports authoring of SOPs, protocols and reports
- LIMS (LabVantage) sample result entry, execution of Electronic Assay Forms in LIMS
- Perform HPLC and NaOH plate reader-based assays in support of manufacturing process stat testing as needed
- Stability program support
- Managing/stocking of QC lab supplies
- Write/revise SOPs, protocols and reports
- Complete and maintain cGMP documentation for work performed.
- Participate in authoring quality systems records such as deviations, change controls, CAPAs
- Establish and maintain a safe laboratory working environment
- Minimum education required: Bachelor’s degree in a relevant scientific discipline
- Minimum experience required: 0-2 years in a laboratory setting with focus in analytical chemistry
- Minimum knowledge required: general laboratory operations (Pipette use, pH, reagent prep, etc.)
- Hands on experience with HPLC instrumentation and Software
- Minimum skills required:
- Technical writing
- Proficiency with Microsoft Office Programs
- Familiarity with electronic databases (e.g. LIMS, SAP, LMS)
- Practical working knowledge of HPLC/ UPLC and related software.
- Strong written and oral communication skills as well as organizational skills
- Knowledge of industry standards and guidelines
- Demonstrated ability to work effectively under established guidelines and instructions
- Ability to collaborate effectively in a dynamic, cross-functional matrix environment.
- Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations.
He's a natural people person
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