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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