Senior QC Technician Job Oceanside area,California USA,Business

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 (Lab Ware, Core Lims, Lab Vantage)
Experience with ELN/LES systems (especially ONELab from Biovia)
Experience with laboratory software such as Empower, LabX, Chromeleon, Mass Hunter, or Open Lab
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

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