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Quality Control Scientist
Quality Control ScientistCynet Systems • Ridgefield, NJ
Quality Control Scientist

Quality Control Scientist

Cynet Systems • Ridgefield, NJ
[job_card.30_days_ago]
[job_preview.job_type]
  • [job_card.full_time]
[job_card.job_description]

Job Description:

Pay Range: $40hr - $45hr
  • Exceptional knowledge of USP, EU and ISO regulations is a must.
  • The candidate must have previous quality control microbiology experience in bioburden testing, membrane filtration, sterility isolator testing, conductivity, total organic carbon, endotoxin assays.
  • Basic knowledge of aseptic manufacturing environmental monitoring of Grade A-D Areas.
  • Validation protocol writing, review and execution (or over seeing validation execution).
  • SOP review, creation and approval.
  • OOS investigations writing/review and approval.
  • Mentor junior Analysts on testing, trouble shooting and Lab related items
  • Ensure compliance with all cGMP standards, safety and environmental regulations and company SOPs.
  • Provide advice to subordinates based on general policies and management guidance.
  • Ensure that high level projects are completed on schedule and accurately.
  • Data review of EM sampling, LIMS, logbooks, and other miscellaneous lab data.
  • Participate in Change Control meetings as the Microbiology Subject Matter Expert and initiate change controls as required.
  • Support regulatory, third party and internal audits when required.
  • Conveys complex information in a concise manner.
  • Motivate and Develop teams.
  • Interact with Project Teams and cross-functional groups related to site operations.
Analyst Qualifications:
  • The Micro QC Scientist I is expected to act on and demonstrate the The LEAD competencies:
  • Act for Change: Embrace change and innovation and initiate new and improved ways of working.
  • Cooperate transversally: Collaborate effectively with peers, stakeholders and partners across the organization to positively impact business results.
  • Develop People: Take responsibility for developing one’s self and mentor other Micro Personnel in anticipation of future business needs or to assist the micro department.
  • HSE
  • It is required that individuals care for their own safety and wellbeing.
  • Individuals must promote a safe working environment for employees and contractors working in their area of responsibility.
  • The individual must support all and site HSE policies, and ensure that work performed complies with local HSE regulations.
  • Individuals must complete all required HSE trainings.
  • Everyone is required to report all accidents and incidents and support investigations in their areas of responsibility.
  • Individuals must ensure timely closure of HSE actions owned by their departments.
Requirements:
  • Education / Experience Physical Requirements include the capacity to lift and carry up to 20 pounds, kneel, reach and stretch, and to stand for at least 4 hours.
  • BA/BS in Microbiology/Biology with 6-10 years of experience is required.
  • A thorough understanding of validation testing.
  • write, execute and report validation studies
  • Practical experience in general microbiology laboratory techniques working with bacteria, yeast and mold.
  • Prior experience with writing protocols, data review, authoring SOPs, Change Controls, out-of-specification investigations, and report writing.
  • Working knowledge of cGMPs in pharmaceuticals/biological/ aseptic/medical device manufacturing.
  • Excellent technical writing skills.
  • Ability to collaborate effectively with personnel and between departments.
  • Strong analytical and problem-solving skills.
  • Make sound judgement from data.
  • Strong communicator.
  • Works independently.
  • Working knowledge of Word, Excel and PowerPoint.
  • Preferred experience with a deviation/CAPA enterprise system.

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Quality Control Scientist • Ridgefield, NJ

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