QC Scientist; Microbiology

The Fountain Group is currently seeking a QC Scientist (Microbiology) for a prominent client of us. This position is located in Ridgefield, NJ. Details for the position are as follows:

Shift Details:

• 100% ONSITE:
  Monday-Friday 8am-4:30pm
• Some flex in the start and end times may be allowed; weekend work and overtime as required.

Job Description:

• Overview:
  • The Micro QC Scientist I is part of the Quality Assurance Department at Ridgefield, NJ.
  • This role is responsible for providing direction, mentoring, and completing high level projects for the Micro team.
  • This position also includes product testing, release EM Monitoring, data review, and validation.
• Responsibilities:
  • Exceptional knowledge of USP, EU and ISO regulations 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 overseeing 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.
  • Participates in Change Control meetings as the Microbiology Subject Matter Expert and initiates 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

Qualifications:

• BS (6+ years) or MS (4+ years) within QC Microbiology
• QC Microbiology experience (bioburden testing, membrane filtration, sterility isolator testing, conductivity, total organic carbon (TOC), endotoxin assays)
• Strong understanding of validation testing / writing / execution / validation reports
• General microbiology methods (working with yeast / bacteria / mold)
• GMP background (pharma / biologics / medical device)
• Data review of EM sampling, LIMS, logbooks, and other miscellaneous lab data
• Quality Background (Writing Protocols | Data Review | Authoring SOPS | Change Controls | Out of Specification Investigations | OOS Report Writing & Review | Deviation / CAPA Enterprise System)

Compensation: $45 per hour