6 Month Contract
Norwood, MA
Shift: WED-SAT, 2nd shift - *Please also note that all candidates must work one week on 1st shift, M-F, before moving to their assigned shift.
PR: $40.65
Job Summary
In this role, you will perform cGMP QC Chemistry testing for QC Chemistry, release, stability and in process samples. This role may support special projects as needed.
Job Responsibilities
- Performs routine analytical chemistry testing such as Wet chemistry which includes APP, Osmolarity, Particle analysis, Dynamic Light Scattering, etc.
- Perform basic HPLC testing and NaOH plate reader-based assays in support of manufacturing process stat testing as needed
- 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 as needed.
- LIMS (LabVantage) sample result entry, execution of Electronic Assay Forms in LIMS
- Stability program support
- Managing/stocking of QC lab supplies
- Complete and maintain cGMP documentation for work performed.
- Participate in authoring quality systems records such as lab events, deviations and CAPAs as needed.
- Establish and maintain a safe laboratory working environment.
- Follow all relevant GxP regulations, guidelines, and company policies to ensure compliance with regulatory and internal requirements.
- Execute tasks precisely as defined in internal guiding documents including but not limited to standard operating procedures (SOPs) and work instructions.
- Follow Good Documentation Practices and Data Integrity requirements to ensure data, documentation, and records are completed and maintained for use by the business and available to support audits or inspections.
- Complete training in assigned required learning plan according to the defined timing and the prescribed requalification cadence.
- Additional duties as may be assigned from time to time
Education & Qualifications
- Level I: BA/BS in relevant scientific discipline & 0-2 years of Laboratory experience
- Level II: BA/BS in relevant scientific discipline & 2 years of Laboratory experience.
- Demonstrated aptitude or ability to learn in order to gain a strong understanding of GxP regulations.
- A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.
