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Scientist, QC Investigations

Edison-New Brunswick Metro Area, NJ

Posted: 10/09/2019 Job Type: Scientific Job Number: JN -102019-25784

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.

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

Previous experience in execution of OOS/OOE/OOT investigations and deviations

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