QC Analyst (Biotechnology)

Location: Novato, California, United States; onsite Wednesday through Saturday. Swing shift: 1:00 p.m.–11:30 p.m.

Company

hirify.global is a biotechnology company developing and manufacturing therapies for rare genetic diseases.

What you will do

• Perform analytical assays on in-process intermediates and drug products under cGMP guidelines.
• Receive and accession samples, assign batches, calculate results, and report findings within required timelines.
• Evaluate assay validity, analyze results against specifications and trends, and support investigations of atypical results.
• Prepare reagents, monitor laboratory supplies, maintain housekeeping standards, and support inspection readiness.
• Contribute to method validation, method transfers, technical studies, equipment validation, and process improvements.
• Train less experienced staff on qualified analytical methods and communicate compliance risks or deviations.

Requirements

• Bachelor of Science degree.
• 0–3 years of relevant laboratory experience; quality control experience is preferred.
• Experience with quality management systems, current Good Manufacturing Practices, and QC principles.
• Working knowledge of analytical activities such as protein determination, UV absorbance, enzyme activity, HPLC/UPLC, and method validation.
• Strong documentation, written and verbal communication, computer literacy, and proficiency in Microsoft Word and Excel.
• Ability to work onsite Wednesday through Saturday on the 1:00 p.m.–11:30 p.m. swing shift, with flexibility for additional hours when required.

Nice to have

• Experience with Microsoft PowerPoint.
• Familiarity with BINOCS or similar scheduling systems.
• Familiarity with SAP or similar enterprise systems.

Culture & Benefits

• Work within a technical operations organization supporting clinical and commercial drug manufacturing.
• Participate in environmental protection, injury prevention, EHS training, and continual improvement initiatives.
• Contribute ideas focused on operational excellence, laboratory efficiency, and method optimization.