Senior QC Technician

Senior QC Technician, Quality Control, BIOVIA, Laboratory Automation, GMP, ISO, LIMS, ELN, LES, Laboratory Systems, Pharmaceutical Quality Control, Data Integrity, Laboratory Workflow Design, Chromatography, Analytical Chemistry, Method Validation, Computer System Validation, LabWare, LabVantage, Quality Assurance, Biotechnology Jobs, Contract QC Technician. In this role, you will collaborate with scientists, laboratory personnel, and business stakeholders to design, enhance, and support automated laboratory workflows and digital laboratory solutions.

Senior QC Technician Advance Quality Control Innovation in a Regulated Laboratory Environment
We are seeking an experienced Senior QC Technician (Contract) to support the development, optimization, and automation of laboratory workflows within a Quality Control environment. This is an excellent opportunity for a professional with a strong combination of laboratory science, quality control, and laboratory software expertise to help drive process efficiency, data integrity, and continuous improvement initiatives.

In this role, you will collaborate with scientists, laboratory personnel, and business stakeholders to design, enhance, and support automated laboratory workflows and digital laboratory solutions.
Key Responsibilities Laboratory Workflow & System Development

• Create and maintain automated laboratory workflows and laboratory recipes within the BIOVIA software platform.
• Modify and enhance existing BIOVIA-based recipes used in Quality Control laboratories.
• Design, optimize, and improve laboratory processes and workflows in collaboration with end users.
• Partner with stakeholders to gather requirements, evaluate feedback, and recommend system enhancements.

Software Testing & Process Improvement

• Report and track software defects and support testing of new functionality.
• Assist with system improvements, upgrades, and implementation initiatives.
• Design and enhance reporting capabilities, interfaces, and user experiences within laboratory systems.
• Support ongoing continuous improvement efforts to increase efficiency and compliance.

Documentation & Compliance

• Prepare, review, and maintain documentation in a regulated laboratory environment.
• Ensure compliance with Good Documentation Practices (GDP) and data integrity requirements.
• Support adherence to industry regulations, quality standards, and laboratory procedures.

Required Qualifications Technical & Laboratory Expertise

• Experience creating and modifying BIOVIA laboratory recipes for Quality Control environments.
• Strong scientific background in biotechnology, chemistry, biochemistry, microbiology, analytical chemistry, or a related discipline.
• Experience working in regulated laboratory environments, including ISO and/or GMP settings.
• Hands-on knowledge of laboratory techniques such as:
  • Chromatography
  • Spectrometry
  • Coulometry
  • Particle analysis
• Understanding of laboratory processes, including sample lifecycle management, in-process controls (IPC), and certification activities.
• Knowledge of BPMN fundamentals and workflow design concepts.
• Understanding of data integrity principles and regulated laboratory operations.

Professional Skills

• Strong analytical, problem-solving, and communication abilities.
• Ability to collaborate effectively with cross-functional and international teams.
• Proactive mindset with the ability to manage multiple priorities and drive solutions independently.

Preferred Qualifications

• Knowledge of industry regulations and standards, including Ph. Eur., USP, ICH, and MHRA guidelines.
• Experience with Laboratory Information Management Systems (LIMS), including:
  • LabWare
  • CoreLIMS
  • LabVantage
• Experience with Electronic Lab Notebook (ELN) and Laboratory Execution Systems (LES), particularly BIOVIA ONE Lab.
• Familiarity with laboratory software platforms such as:
  • Empower
  • LabX
  • Chromeleon
  • MassHunter
  • OpenLab
• Knowledge of:
  • Computer System Validation (CSV)
  • GAMP5
  • 21 CFR Part 11
  • EU Annex 11
• Experience supporting pharmaceutical method validation, cleaning validation, or instrument qualification activities.
• Familiarity with Agile methodologies, including Scrum and SAFe.
• Understanding of Business Analysis principles and code version control concepts.

Education & Experience
Candidates should possess one of the following:

• Bachelor's degree in Computer Science, Software Development, Biology, Biochemistry, Life Sciences, or related field, with 8-11 years of relevant experience, OR
• Master's degree in a related field, with 6-9 years of relevant experience, OR
• PhD/JD in a related discipline, with 3-6 years of relevant experience.

Additional requirements:

• Minimum 8 years of pharmaceutical industry experience.
• Minimum 5 years of experience in Quality Control and/or Software Development roles.

Work Environment

• Primarily office-based work environment.
• May involve exposure to laboratory chemicals and hazardous materials.
• Ability to lift up to 30 pounds may be required.

Keywords
Senior QC Technician, Quality Control, BIOVIA, Laboratory Automation, GMP, ISO, LIMS, ELN, LES, Laboratory Systems, Pharmaceutical Quality Control, Data Integrity, Laboratory Workflow Design, Chromatography, Analytical Chemistry, Method Validation, Computer System Validation, LabWare, LabVantage, Quality Assurance, Biotechnology Jobs, Contract QC Technician.