Scientist, QC Investigations (19-00963) – NJ – Morris Plains

**Minimum 5 years of relevant experience in pharmaceuticals, biologics, microbiology, or aseptic manufacturing

**Required to have experience in performing Cell based assays and Flow Cytometry techniques in the laboratory environment

Duties:
Lead and perform QC deviation investigations to adequately identify root cause and assign appropriate corrective and preventative actions (CAPAs) to prevent reoccurrence to support QC department operations

Lead and perform out-of-specification (OOS)/out-of-expectation (OOE)/out-of-trend (OOT) investigations to support QC department operations
Employ standardized root cause analysis, investigation tools and methodologies
Utilize Quality Management Systems such as Trackwise for owning QC investigations and tracking statuses
Train on Bioanalytics, Microbiology, and Raw Material test methods to build a knowledge base to support compliance-related activities
Participates in cross-functional teams for 5S/lean lab projects and continuous improvement programs to maximize efficiency
Participate in internal and external GMP and HSE audits
Timely delivery on commitments and departmental KPIs.
 

Skills:
Minimum 5 years of relevant experience in pharmaceuticals, biologics, microbiology, or aseptic manufacturing
Previous experience in execution of OOS/OOE/OOT investigations and deviations
Knowledgeable in FDA/EMA/JP guidelines and cGMP requirements
Knowledge and familiarity of LabWare LIMS and/or other QC data systems
Knowledge of Quality Management Systems, such as Trackwise, ESOPS, and Subway
Proficient using Microsoft Office (Word, Excel, PowerPoint, Project)

Source: Job Diva – Job Listing

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