Scientist, QC Investigations (19-00927) – NJ – Morris Plains

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.
Ensure adherence to all company policies and procedures relating to current Good Manufacturing Practices, Standard Operating Procedures and Health, Safety and Environmental Protection regulations
Other duties as assigned

To support both domestic and international activities, working off shift or weekends may be necessary on short notice
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)
Detail-oriented with expertise in problem solving and solid decision making abilities
Strong written and verbal communication skills are essential
To support both domestic and international activities, working off shift or weekends may be necessary on short notice
May use a computer for extended periods
Must be proactive, responsive, and able to work independently
Strong analysis and decision making skills surrounding documentation
Source: Job Diva – Job Listing

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