Analyst, Quality Control

The role

We are looking for an Analyst, Quality Control located in South San Francisco, California. The Analyst, Quality Control will be responsible for ensuring that the reagents and instruments (Syntax) produced meet company requirements. This compliance will be assessed by running QC tests on the Syntax instrument, performing enzymatic synthesis on a liquid handler, analyzing by capillary electrophoresis, and documenting the results, for the reagents involved in enzymatic DNA synthesis (such as buffers). Some other tests may include pH, conductivity, spectrophotometry UV, visual appearance, etc.

He/she/they will be primarily collaborating with the manufacturing and product development teams based in SSF. They will be directly involved in the reporting of DNA Script product performances and contribute to their improvement. The position will require significant interdisciplinary communication: mostly with the manufacturing teams in France and the US, the R&D synthesis team (France), and the product development team (France & USA).

He/she/they will be the primary operator for most reagent validation experimental runs conducted inside the Quality Control department, with compliance to ISO 13485. The ideal candidate must be autonomous, eager to learn, proactive, meticulous, and curious. This person must be adaptable, communicative, and able to handle multiple tasks in parallel.

Responsibilities

• Project Lead for Reagent Validation Process Establishment in SSF:
• Technical lead for the maintenance and good performances of the equipment used (liquid handler and capillary gel electrophoresis system).
• Take lead on the effort to align reagent validation instrumentation practices in the QC Paris lab to the QC lab in SSF.
• Work with vendor to ensure that instrument is functioning properly.
• Work with internal colleagues (mostly based in Paris) to ensure that liquid handler functions as expected for reagent validation methodology and process implementation.
• Project Lead for Reagent Validation Efforts in SSF-QC
• Perform all the following analyses on standard reagents undergoing QC validation testing. Document results in real time on prescribed forms in QC.
• Synthesis Reactions using automated Liquid Handler.
• Optical Density Readings using Spectrophotometer
• Purity and Length of Oligos Synthesized using Capillary Gel Electrophoresis
• pH and Conductivity
• Guide more junior members of QC team in methodology and work together to build processes under the guidance of QC Manager.
• Follow Work Instruction, Standard Operating Procedures (SOPs), Test Methods, and other documentation written to validate manufactured batches of reagents and instruments.
• Communicate results to internal stakeholders within the QC department.
• Take the lead with communicating the results to the Manufacturing team to release the product.
• Release lots of reagents for use via NetSuite.
• Report data to QC team databases to assist the QC Manager in data trending and tracking as needed.
• Present findings in team and department meetings as needed.
• QC Lab Operations & Lab Establishment:
• Assist with purchasing all equipment needed to perform these duties for reagent validation.
• Assist with maintaining inventory of reagents, consumables, stocks, and ordering as needed.
• Perform inter-team lab operation duties such as receiving deliveries, follow-up on quotes, new orders, backorders, and alternative solutions.
• Maintain a clean work environment including glassware, instrumentation, and overall workspace.
• Work with the purchasing department to ensure follow-up on quotes, new orders, etc.
• Provide input to QC Manager for logistical needs for scaling up efforts once QC lab moves to new facility.
• General Quality Duties:
• Participate in writing and reviewing of the documentation needed to perform the tasks assigned (Test Methods, Work Instructions, SOPs, …).
• Actively contribute to critical company milestones, with a willingness to work outside immediate area of expertise when required.

Qualifications and experience

Essential

• Bachelor's degree in Biological or Chemistry Sciences with 5 years of relevant experience or a M.S. degree with minimum 3 years' experience in Biotechnology sciences, Molecular Biology, Quality, or Manufacturing.
• At least 3 years of full-time experience in a life science laboratory setting.
• Experience working under GLP (Good Laboratory Practices) and/or following documentation and compliance practices listed in: ISO 9001/13485, 21CFR Part 820 or BPF/GMP.
• Experience with laboratory safety procedures and documentation.
• Seeking an autonomous, proactive, meticulous, and curious individual.
• Excellent written and verbal communication skills in English.
• Demonstrated ability to work in multidisciplinary teams.
• Strong documentation skills and ability to effectively communicate verbally and in writing.

Desirable

• Experience in a regulated environment (i.e. Manufacturing or Quality).
• Education in Biotechnology, Quality, or Manufacturing related programs.
• Experience in the biotech/pharma industry.
• Experience in using liquid handling systems, capillary electrophoresis.
• Experience in reagent preparation, validation, and qualification.
• Experience in Molecular Biology applications including but not limited to: qPCR, ddPCR, and NGS.
• French communication skills are a plus but not required for this role..

Additional Information

• Job located in South San Francisco
• Start date: ASAP

Contact

marissa.kane@dnascript.co