• Rho
  • $75,610.00 -127,990.00/year*
  • Bergenfield , NJ
  • Entertainment
  • Full-Time
  • 30 W Clinton Ave

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SUMMARY:By using Root Cause analysis training, assist the operations department in investigation of excursions, non-conformances, deviations, etc. to improve the production, packaging, engineering, and warehousing processes at the Somerset plant by implementing preventative actions resulting in the reduction of repeated excursions. ESSENTIAL FUNCTIONS:- Using root cause determination techniques, perform Deviation, Nin-Conformance, OOS, OOT, field complaint and event excursion investigations to determine the root cause and effective preventative action implementation to prevent recurrence of the event.- Manage multiple investigations in different stages of the process to efficiently meet compliance deadlines and product release dates.- Work with cross-functional teams to develop and track CAPA plans.- Working with operations personnel in performance of effective investigations.- Evaluate trends of investigations and CAPA's to identify major areas of opportunity for improvement. ADDITIONAL RESPONSIBILITIES:- Ability to work effectively as a team and independently.- Proficient at Microsoft Outlook, Excel, and Word.- Strong communication skills and presentation skills- Ability to abide by quality standards.


EDUCATION AND/OR EXPERIENCE:Bachelor of Science in a Quality / Process related or Engineering field, or equivalent experience. 2 years of root cause analysis experience in a manufacturing, packaging, engineering, and distribution environment, MUST be pharmaceutical experience. Track Wise experience is a plus but is not required. PHYSICAL DEMANDS, MENTAL REQUIREMENTS, AND WORK ENVIRONMENT:The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations must be made to enable individuals with disabilities to perform the essential functions.While performing the duties of this job, the employee is regularly required to sit, stand, walk, use hands to finger, handle or touch, reach above shoulder, talk and hear. Specific vision abilities required by this job include close vision, distance vision, depth perception and ability to adjust to focus.Mental Requirements include:- Ability to hear accurately the spoken word with moderate office noise or plant noise.- Ability to apply deductive reasoning and understand complicated issues.- Ability to receive instructions and follow work rules and company policies.- Ability to follow safety and security practices.- Ability to meet deadlines and effectively deal with office stress.- Ability to accurately communicate ideas, facts, and technical information.- Maintain confidentiality of certain information. WORK ENVIRONMENT: - Pharmaceutical, sterile cleanroom requiring special gowning.- Exposure to equipment use and maintenance / calibration for sterilization, depyrogenation, washing, filling, packaging, etc. pharmaceutical products.- Manual and high speed packaging operations.- Pick and packaging of pharmaceutical products for commercial distribution.

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* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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