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Job Description
QC Lead Investigator at Consultant Specialists, Inc. (CSI) QC Lead Investigator at Consultant Specialists, Inc. (CSI) in Gloucester City, New Jersey Posted in 13 days ago.
Type:
full-time
Job Description:
We have two positions Position 1 Pitch - QC Lead Investigator / Event Owner (Lab Equipment) | Philadelphia, PA Join the Quality Control organization at Spark in Philadelphia as a QC Lead Investigator focused on laboratory equipment investigations and quality events. This contract role is ideal for someone experienced in QC/QA within regulated environments who enjoys digging into root cause, driving CAPAs, and improving lab systems. You'll lead equipment?related investigations, manage deviations and change controls, support regulatory inspections, and serve as a system administrator for key QC lab platforms (Empower, Qx Manager, LabX, SoftMax, qPCR, etc.). Strong documentation, cross?functional collaboration, and technical writing skills are essential. Candidates should bring a Bachelor's in a scientific or engineering field , hands?on experience in GMP/regulated operations, and familiarity with root?cause tools (5 Whys, Fishbone, FMEA). Experience with Veeva Vault QMS is a plus. This role is on?site ~80% with standard business hours and some flexibility. If you're analytical, detail?driven, and ready to support high?visibility QC operations in a fast?paced biotech environment, this is a strong opportunity to make an impact. Position 2 Pitch - QC Lead Investigator / Event Owner | Philadelphia, PA (Onsite) Spark's Quality Control organization in Philadelphia is looking for a QC Lead Investigator/Event Owner to drive laboratory equipment investigations and quality events in a fast?paced, highly regulated biotech environment. This contract role is ideal for someone who thrives on root?cause analysis, CAPA execution, and cross?functional problem?solving. In this position, you'll lead equipment?related investigations, manage deviations and change controls, support regulatory inspections, and partner closely with QC, QA, Lab Systems, and IT teams. You'll also perform system admin tasks for key QC lab platforms and ensure documentation meets cGMP and global quality standards. Candidates should bring a Bachelor's in a scientific or engineering field , hands?on QC/QA experience in regulated manufacturing, and familiarity with tools like Empower, Qx Manager, LabX, SoftMax, or qPCR systems. Strong technical writing, analytical thinking, and root?cause methodologies (5 Whys, Fishbone, FMEA) are essential. Experience with Veeva Vault QMS is a plus. This is an onsite role (~80%) with standard business hours and some flexibility. If you're detail?driven, collaborative, and ready to support high?visibility investigations that directly impact product quality and compliance, this is a strong opportunity to step into a key role within QC.
