QC Lead Investigator/Event Owner

Avispa Technology•Philadelphia, PA

6d•$45•Onsite

About The Position

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.

Requirements

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.
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 team and refer to SOPs/policies for guidance.
Exercise judgment within defined procedures and practices to determine appropriateaction.
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.

Nice To Haves

Preferred experience with Lab Equipment/Systems/Software (Empower, Qx Manager, LabX, Softmax, qPCR, etc).
Preferred experience with deviations, change controls, and CAPAs

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.
Perform risk and impact assessments for QC Operations as assigned by Functional Manager.
Supporting QC and GxP Systems in regulatory inspections, as assigned by Functional Manager.
Maintain good documentation practices.
Comply with all SOPs, policies, and laboratory safety procedures.
Update SOPs, Protocols, supporting documents as needed.
Write and manage change controls for the implementation of new laboratory equipment, systems, and software.
Perform laboratory system administrator actions such as user account creation, template creation, method locking, etc.
Use Lab Equipment/Systems/Software (Empower, Qx Manager, LabX, Softmax, qPCR, etc)