Process Group Chemist
Listed on 2026-07-24
-
Manufacturing / Production
Quality Engineering -
Quality Assurance - QA/QC
Quality Engineering
The Fountain Group is currently seeking a Process Group Chemist for a prominent client of ours. This position is located in Carlsbad, CA. Details for the position are as follows:
Job Title: Process Group Chemist
Location: Carlsbad, CA Onsite
Pay Rate: $32–38/hr (W2)
Duration: 1 Year
The Process Group Chemist supports the manufacturing of diagnostic products in a regulated laboratory environment while ensuring compliance with QSR, ISO, and GMP requirements. Responsibilities include formulation and quality control of bulk reagents, review and reconciliation of manufacturing documentation and work orders, product transfers, process troubleshooting, and continuous improvement initiatives. The role also supports manufacturing schedule adherence, Engineering Change Orders (ECOs), Device History Record (DHR) review, SAP work order reconciliation, and training on manufacturing procedures and SOPs.
Candidates will work with cross-functional teams including Process Engineering, R&D, Planning, Inventory Control, and Quality to support production and validation activities.
- Bachelor's degree in Chemistry, Biochemistry, Life Sciences, Applied Sciences, or a related scientific discipline (or equivalent experience).
- GMP, QSR, and ISO 9001 regulated manufacturing
- Laboratory manufacturing of diagnostic products
- Bulk formulation and reagent preparation
- ELISA and immunoassay techniques
- Assay development
- Protein purification
- Antibody conjugation
- Solution preparation
- Quality Control (QC) testing
- Device History Records (DHR)
- Engineering Change Orders (ECO)
- Manufacturing documentation and work order reconciliation
- SAP S/4
HANA - Bill of Materials (BOM)
- Manufacturing process troubleshooting
- Product transfer and validation support
- Data analysis and statistical evaluation
- Microsoft Excel
- Experimental design
- 3–4 years of GMP manufacturing experience
- Lateral flow device manufacturing
- Controls and calibrators manufacturing
- Microtiter systems
- Nonconformance (NCMR) investigations
- Deviation management
- Validation protocols
- Quality Test Plans (QTP)
- Pharmaceutical, biotechnology, medical device, or diagnostics manufacturing experience
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