QC Lead Investigator/Event Owner (Laboratory Equipment)

QC Lead Investigator/Event Owner (Laboratory Equipment)

A leading biotechnology company is seeking a Lead Investigator/Event Owner (Laboratory Equipment) to join the Quality Control team. The position is responsible for conducting comprehensive investigations, deviations, change controls and CAPAs for the Quality Control Department in accordance with cGMPs, international regulations, and Genentech procedures focused on QC Laboratory Equipment.

QC Lead Investigator/Event Owner (Laboratory Equipment) Responsibilities:

• Collaborating with QC, Lab Systems Engineers, and Quality Assurance to conduct comprehensive laboratory equipment investigations, deviations, quality incidents, change controls, and CAPAs while ensuring timely completion.
• Support implementation of relevant corrective and preventive actions.
• System administrator of QC Lab Equipment.
• Perform risk and impact assessments for QC Operations as assigned by Functional Manager.
• Supporting QC and GxP Systems in regulatory inspections, as assigned by the Functional Manager.
• Maintain good documentation practices.
• Comply with all SOPs, policies, and laboratory safety procedures. Update SOPs, Protocols, and supporting documents as needed.
• Use Lab Equipment/Systems/Software (Empower, Qx Manager, LabX, Softmax, qPCR, etc)

QC Lead Investigator/Event Owner (Laboratory Equipment) Qualifications:

• Bachelor's degree in a scientific, engineering, or quality-related field (or equivalent experience).
• Proven experience in Quality Control, Quality Assurance, or a related role in manufacturing or regulated industries.
• Preferred experience with Lab Equipment/Systems/Software (Empower, Qx Manager, LabX, Softmax, qPCR, etc).
• Strong knowledge of quality standards, regulations, and processes (e.g., FDA, ISO, GMP).
• Experience with root cause analysis techniques such as 5 Whys, Fishbone diagrams, and FMEA.
• Proficiency in Veeva Vault QMS
• Experience in technical writing.
• Excellent problem-solving and analytical skills.
• Proficient in maintaining detailed, accurate, and organized documentation.
• Ability to communicate effectively across all organizational levels.
• Discuss investigational findings and/or root cause with senior members of the team and refer to SOPs/policies for guidance.
• Exercise judgment within defined procedures and practices to determine appropriate action.
• Must be comfortable in the fast-paced, biotech environment and interact with multi-disciplinary teams
• Position is an office-based role with lab-based activities and therefore requires the candidate to wear PPE as required by lab SOPs.
• Experience in troubleshooting laboratory equipment and laboratory software systems in regulated environments.
• Understanding of validated equipment lifecycle states and GxP equipment compliance requirements.
• Experience owning and leading equipment or system investigations, including root cause analysis and resolution activities.
• Knowledge of configuration specifications, user requirement specifications (URS), system qualification documentation, and equipment administration procedures.

Shift:

• Standard hours 8am to 5pm - some flexibility to work earlier/late as needed.