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QC Associate I: Chemistry
3 months ago
6 Month Contract
Norwood, MA
PR: $30-40/hour
Shifts:
WED-SAT, 2nd shift: 2:00pm-12:00am
OR
SUN-WED, 3rd shift: 10:00pm-8:00am
OR
WED-SAT, 3rd shift: 10:00pm-8:00am
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
- Education: BA/BS in relevant scientific discipline
- Experience: 0-2 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.
