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Scientist, QC Investigations

Edison-New Brunswick Metro Area, NJ

Posted: 03/04/2019 Job Type: Scientific Job Number: JN -032019-23833
Duties:
  • As a certified investigator, support compliance-related activities in the Quality Control (QC) department (Bioanalytics, Microbiology and Raw Materials) within established timelines.
  • 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
Skills:
  • 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
  • Must be able to plan, prioritize and execute multiple tasks simultaneously under tight deadlines
  • Must be able to challenge processes to improve quality and efficiency.
  • Possess strong verbal, written technical communication and interpersonal skills.
  • Be able to network within and outside the organization
  • Detail-oriented with expertise in problem solving and solid decision making abilities
  • Strong analysis and decision making skills surrounding documentation
Education:
  • BS/MS or equivalent in biology, chemistry, biochemistry, microbiology or other related science.
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