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QC Microbiology Engineer III

Location : Mahwah NJ US 07430
Job Type : Direct
Reference Code : 20312-AB1
Compensation : 60000.00 - 100000.00 USD/YEAR
Start Date : 09/16/2020
Hours : Full Time
Required Years of Experience : 5
Required Education : BS Engineering or Science
Travel : No
Relocation : No
Job Industry : Pharmaceutical

Job Description :

  • Permanent position for a Quality Control Microbiology Engineer III to support clinical and commercial production, coordinating data for batch release, participating in project and client meetings.

  • Author and revise microbiological testing procedures.

  • Conduct microbiological testing including, growth promotion, microbial identification, sterility testing, Gram stain, and endotoxin.

  • Responsible for documentation according to written Standard Operating Procedures in accordance to cGMP and GDP.

  • Coordinates microbiological testing data for batch release.

  • Provide scientific and technical expertise in project and client meetings and communications.

  • Author and revise SOPs, work instructions, forms, and protocols.

  • Review of investigations and documentation of non-confirming events and environmental excursions.

  • Apply expertise of compliance requirements to maintain an inspection-ready state.

  • Participate and act as subject matter expert during audits and inspections.

  • Develop and train junior QC Microbiology Engineers.

  • Coordinate work orders and process purchase orders for outsourced testing and lab supplies.

Required Qualifications :

  • BS Engineering or Science.

  • Minimum 5 years of experience with microbiological testing in biopharmaceutical industry

  • Strong knowledge of quality systems and ability to interpret Quality standards for implementation and review.

  • Proficient with computer software such as Microsoft Office, MODA and LIMS

  • Experience with Microsoft Visio, Netsuite, and Maximo Asset Management System preferred.

  • Familiarity with ISO and EU standards.

  • Organizational skills, multi-tasking skills, good verbal and written communication skills, computer skills, training abilities, and team-oriented interpersonal skills.

Contact: Allan Berman

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Please send all inquiries to Allan.Berman@TerkoTech.com


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