QC Lead Investigator/Event Owner (Laboratory Equipment)

Dawar Consulting

Philadelphia, Pennsylvania

JOB DETAILS
SKILLS
Biology, Biotech and Pharmaceutical, Change Control, Change Management, Corrective Action, Cross-Functional, Current Good Manufacturing Practice (cGMP), Failure Mode and Effects Analysis (FMEA), Information Technology & Information Systems, Laboratory Equipment, Laboratory Management, Laboratory Systems, Maintain Compliance, Operational Support, Quality Assurance, Quality Control, Real-time PCR (qPCR), Regulations, Regulatory Compliance, Risk Analysis, Root Cause Analysis, Systems Administration/Management, Systems Engineering, Writing Skills
LOCATION
Philadelphia, Pennsylvania
POSTED
6 days ago

Our client, a world leader in biotechnology and life sciences, is looking for a “QC Lead Investigator/Event Owner (Laboratory Equipment)” based out of Philadelphia, PA.<\/b><\/span><\/a>
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Job Duration: Long Term Contract (Possibility Of Extension)<\/span><\/b><\/span>
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Pay Rate : $46/hr on W2 <\/span><\/b><\/span>
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Company Benefits:<\/span><\/b><\/span> Medical, Dental, Vision, Paid Sick leave, 401K<\/span><\/span>
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The Quality Control (QC) team is seeking a Laboratory Equipment Investigation Lead<\/b> responsible for managing investigations, deviations, change controls, and CAPAs related to QC laboratory equipment and systems. The role ensures compliance with cGMP regulations and internal quality procedures<\/b>, while supporting QC operations and regulatory readiness.<\/span><\/span>
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Key Responsibilities:<\/span><\/u><\/b><\/span>
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·       <\/span><\/span><\/span>Conduct and manage QC laboratory equipment investigations, deviations, and quality incidents<\/b>.<\/span><\/span>
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·       <\/span><\/span><\/span>Identify root causes and implement Corrective and Preventive Actions (CAPAs)<\/b>.<\/span><\/span>
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·       <\/span><\/span><\/span>Author and manage change controls<\/b> for laboratory equipment, systems, and software.<\/span><\/span>
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·       <\/span><\/span><\/span>Serve as system administrator for QC laboratory systems<\/b> (user access, templates, method controls).<\/span><\/span>
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·       <\/span><\/span><\/span>Collaborate with QC, Lab Systems Engineering, QA, IT, and cross -functional teams<\/b>.<\/span><\/span>
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·       <\/span><\/span><\/span>Perform risk and impact assessments<\/b> for QC operations.<\/span><\/span>
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·       <\/span><\/span><\/span>Support regulatory inspections and audits<\/b>.<\/span><\/span>
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·       <\/span><\/span><\/span>Maintain cGMP documentation<\/b> and update SOPs and supporting documents as required.<\/span><\/span>
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Qualifications:<\/span><\/u><\/b><\/span>
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·       <\/span><\/span><\/span>Bachelor’s degree in Science, Engineering, Quality, or related field<\/b> (or equivalent experience).<\/span><\/span>
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·       <\/span><\/span><\/span>Experience in QC, QA, or regulated biotech/pharmaceutical environments<\/b>.<\/span><\/span>
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·       <\/span><\/span><\/span>Knowledge of cGMP, FDA regulations, and quality systems<\/b>.<\/span><\/span>
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·       <\/span><\/span><\/span>Familiarity with laboratory systems such as Empower, LabX, SoftMax, qPCR, or similar<\/b> preferred.<\/span><\/span>
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·       <\/span><\/span><\/span>Experience with Veeva Vault QMS<\/b> and root cause analysis methods (5 Whys, Fishbone, FMEA) preferred.<\/span><\/span>
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·       <\/span><\/span><\/span>Strong analytical, documentation, and cross -functional collaboration skills.<\/span><\/span>
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If interested, please send us your updated resume at<\/span><\/span>
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hr@dawarconsulting.com

akansha@dawarconsulting.com

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About the Company

D

Dawar Consulting