The Quality Control Analyst will join our Quality team to be a key player in all scientific and documentation aspects of product development, release, stability, and investigations in support of maintaining and improving processes within the Pre-Clinical Production Team at Synthego.
Available Shift:
-
Swing Shift: 2:30pm – 11:00pm
-
Days: Monday - Friday
What You'll Do:
- Perform automated and manual assays as detailed in established SOPs and QC test method procedures, including raw material, in-process and finished product.
- Conduct QC testing with a variety of analytical techniques such as LC/MS, HPLC, GC, UV/Vis, Endotoxin, Raman spectroscopy, PCR, and NGS.
- Interpret test results against specifications to support material dispositioning.
- Perform testing for product stability, environmental monitoring, endotoxins, and bioburden as required.
- Maintain complete and accurate production records in conformance with GMP and FDA requirements.
- Support routine preventive maintenance, general troubleshooting, general cleanliness and calibration of laboratory equipment.
- Support internal and external customer inquiries and requests as relevant to product quality and integrity.
- Trend EM and QC data results.
- Update departmental SOPs and QC test procedures.
- Order required laboratory supplies, reagents and other consumables.
- Monitor proper storage conditions and expiration dates.
- Dispose of hazardous and biohazardous materials.
- Maintain samples in accordance with established procedures.
- Prepare QC test samples required for QC functional testing.
- Perform other duties as assigned.
About You:
- Bachelor’s degree in Biology, Chemistry, Molecular Biology, or equivalent technical field.
- 1+ years in a regulated Quality Control or similar role with working knowledge of cGMP.
- Be able to analyze, understand and effectively communicate technical material.
- Be able to organize and prioritize tasks in a dynamic work environment.
- Relevant combinations of education, experience, certifications, and merit may be considered upon management review.
-
Nice to Have: Experience with being a team player in QC supporting 24/7 production activities.
Company Perks & Benefits:
- Equity options
- Medical, dental, and vision benefits
- 401k Program
- Catered meals on Tuesday and Thursday
- Paid parental leave
- Flexible paid time off
About Us
Synthego is a genome engineering company that enables the acceleration of life science research and development in the pursuit of improved human health.
Based on a foundation of engineering and chemistry, Synthego leverages automation and machine learning to synthesize high-quality CRISPR reagents for science at scale. Synthego’s mission is to enable agile life science research and development from discovery through clinical trials by providing scientists with comprehensive CRISPR solutions for each phase coupled with full technical and regulatory support from industry-leading experts.
With its technologies cited in hundreds of peer-reviewed publications and utilized by thousands of commercial and academic researchers and therapeutic drug developers, Synthego is at the forefront of innovation, enabling the next generation of medicines by delivering genome editing at an unprecedented scale.
