QC Lead Investigator/Event Owner (Laboratory Equipment)

Job Title: QC Lead Investigator/Event Owner (Laboratory Equipment)
Location: Philadelphia, PA 19104
Pay rate: $36.23 - $47.10/hr
Work schedule: 8 to 5 (On-site in Philadelphia, PA); flexible as needed

Job Overview

The Quality Control (QC) team is seeking a Laboratory Equipment Lead Investigator for the Spark location in Philadelphia. This position is responsible for conducting comprehensive investigations, deviations, change controls, and CAPAs in accordance with cGMPs, international regulations, and company procedures. You will focus specifically on QC laboratory equipment, serving as a system administrator and collaborating with Lab Systems Engineers and Quality Assurance to ensure all quality incidents are resolved timely and effectively.

Job Specifications

• Conduct comprehensive laboratory equipment investigations, deviations, and quality incidents.
• Identify and implement relevant Corrective and Preventative Actions (CAPAs) to support continuous improvement.
• Write and manage change controls for the implementation of new laboratory equipment, systems, and software.
• Serve as a System Administrator for QC Lab Equipment, performing tasks such as user account creation, template creation, and method locking.
• Perform risk and impact assessments for QC Operations as assigned by management.
• Support QC and GxP Systems during regulatory inspections.
• Utilize and manage specialized Lab Equipment/Systems/Software including Empower, Qx Manager, LabX, Softmax, and qPCR.
• Update SOPs, protocols, and supporting technical documentation as needed.
• Maintain strict adherence to Good Documentation Practices (GDP) and laboratory safety procedures.
• Collaborate cross-functionally with IT, Quality Assurance, and Analytical Development teams.
• Bachelor's degree in a scientific, engineering, or quality-related field required.
• Proven experience in Quality Control or Quality Assurance within a regulated manufacturing industry.
• Strong knowledge of FDA, ISO, and GMP standards.
• Proficiency in root cause analysis techniques (5 Whys, Fishbone diagrams, FMEA).
• Proficiency in Veeva Vault QMS and technical writing.
• Ability to work on-site approximately 80% of the time and wear PPE as required.

Benefits:
• Health insurance
• Health savings account
• Dental insurance
• Vision insurance
• Flexible spending accounts
• Life insurance
• Retirement plan

All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.