Associate I, Quality Assurance Chemist
4 days ago
As a leading staffing and recruitment agency, Randstad is committed to finding top talent for prestigious life sciences and biopharma companies. We offer a unique opportunity for individuals to grow and learn in a dynamic environment. Our extensive network of top employers and detailed information about hundreds of positions make us the ideal partner for job seekers.
Responsibilities:- Perform cGMP QC Chemistry testing for QC Chemistry, release, stability, and in-process samples.
- Support special projects as assigned.
- Conduct routine analytical chemistry testing, including Wet chemistry, 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.
- Assist with troubleshooting assay methods and equipment.
- Enter data and support trending.
- Perform general laboratory support activities, including reagent preparation, sample management, equipment maintenance, lab housekeeping, etc.
- Support authoring of SOPs, protocols, and reports as needed.
- LIMS (LabVantage) sample result entry and execution of Electronic Assay Forms in LIMS.
- Stability program support.
- Manage and stock 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: BA/BS in a 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.
Quality control, HPLC, SOP, CAPA, GMP (Good Manufacturing Practice)
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