Senior QC Technician

Spectraforce Technologies; Oceanside (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

Spectraforce Technologies in Oceanside, CA seeks a Senior QC Technician to create automated laboratory workflows within the Biovia suite and to support recipe development for QC laboratories. You will collaborate with stakeholders to identify needs and propose new functionalities, while ensuring regulatory compliance and robust data integrity.

Responsibilities include defect reporting, feature testing, and improving laboratory reporting interfaces, as well as partnering with end users to design

Qualifications

• Must be able to create or modify Biovia-based recipes for QC workflows.
• Domain knowledge in biotechnology or analytical chemistry is required.
• Experience in regulated lab environments (ISO/GMP) is required.
• Familiarity with lab techniques such as chromatography and spectroscopy.
• Experience creating documentation (GDP) and data integrity concepts.
• BPMN fundamentals and user-focused workflow design experience.

Responsibilities

• Create automated laboratory workflows and support Biovia recipe development.
• Collaborate with stakeholders to gather feedback and propose enhancements.
• Report defects, test features, and support system improvements.
• Design and enhance reporting within laboratory systems.
• Work with end users to optimize complex workflows and processes.
• Prepare and maintain documentation in regulated lab environments.

Skills

Analytical thinking

Communication skills

Problem solving

Team collaboration

Proactive attitude

Data integrity understanding

BPMN fundamentals

Documentation practices

Education

BS/BA degree

Master's degree

PhD/JD (relevant field)

8+ years pharmaceutical experience

Tools

Biovia

LabWare

CoreLims

LabVantage

Empower

LabX

Chromeleon

MassHunter

OpenLab

Job description

Position Title: Senior QC Technician

Work Location: Oceanside, CA, 92056

Assignment Duration: 24 months

Work Arrangement: Onsite

Position Summary

• Create automated laboratory workflows and support development of laboratory "recipes" within the Biovia software system.
• Collaborate with business stakeholders to gather feedback and propose new functionalities

Key Responsibilities

• Create automated laboratory workflows and support development of laboratory "recipes" within the Biovia software system.
• Collaborate with business stakeholders to gather feedback and propose new functionalities
• Report defects, test new software features, and support system improvements
• Design and enhance reporting functionalities and interfaces within laboratory systems
• Work with end users to design and optimize complex workflows and processes
• Prepare and maintain documentation in regulated laboratory environments

Qualification & Experience

• An individual with the ability to create new and/or modify existing Biovia-based recipes for use within the Quality Control Laboratory.
• Domain knowledge in biotechnology, chemistry, biochemistry, microbiology, analytical chemistry, or related fields
• Experience working in a regulated laboratory environment (ISO or GMP)
• Experience with laboratory techniques such as chromatography, spectrometry, coulometry, or particle analysis
• Good understanding of laboratory processes (certification, IPC, sample cycle, etc.)
• Experience in creating documentation (GDP)
• BPMN fundamentals and ability to work with end users on workflow design
• Understanding of Data Integrity concepts
• Strong analytical, communication, and problem-solving skills
• Proactive attitude and ability to work effectively in international teams

Nice to have

• Knowledge of Ph. Eur, USP, ICH, MHRA, and related standards
• Experience with LIMS systems (LabWare, CoreLims, LabVantage)
• Experience with ELN/LES systems (especially ONELab from Biovia)
• Experience with laboratory software such as Empower, LabX, Chromeleon, MassHunter, or OpenLab
• Knowledge of CSV, GAMP5, 21 CFR Part 11, and EU Annex 11
• Experience in pharmaceutical method validation, cleaning validation, or instrument qualification
• Familiarity with Agile methodologies (Scrum, SAFe) and Business Analysis concepts
• Understanding of code versioning concepts

Education and Experience

• BS/BA degree and 8-11 years of experience in Computer Science (Software Development) or Life Science (Biology, Biochemistry) or Equivalent
• Master's degree and 6-9 years of experience in Computer Science (Software Development) or Life Science (Biology or Biochemistry) or Equivalent
• PhD/JD and 3-6 years experience in Computer Science (Software Development) or Life Science (Biology or Biochemistry) or Equivalent
• Minimum 8 years pharmaceutical experience
• Minimum 5 years of experience in a Software Development role or Quality Control.

Work Environment

• Works in an office environment.
• May be exposed to hazardous materials and chemicals.
• May be required to lift up to 30lb