What are the responsibilities and job description for the Senior QC Technician position at Spectra Force?
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
Salary : $3,571 - $32,000