Quality Control Microbiology Engineer III

Quality Control Microbiology Engineer III

Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT and Human Resources disciplines in New Jersey. The Quality Control Microbiology Engineer III will support two local sites. Serving as a support role to clinical and/or commercial production. The QC Microbiology Engineer III will coordinate data for batch release, participate in project/client meetings, and author/revise microbiological testing procedures. Additionally, the incumbent will perform microbiological testing including, but not limited to, growth promotion, microbial identification, sterility testing, Gram stain, and endotoxin. Under the direction of the Associate Manager of Microbiology, responsibilities of the

• Documentation according to written Standard Operating Procedures in accordance to Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP).
• Coordinates microbiological testing data for batch release
• Participation in project/client meetings and communications, providing scientific and technical expertise
• Authoring/revising Standard Operating Procedures, 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/inspections
• Develop and train QC Microbiology Engineer II on relevant business processes
• Processing of purchase orders for outsourced testing and lab supplies
• Coordinates work orders
• Other duties as assigned

Requirements

• BA/BS in a science or relevant field required or equivalent experience
• Minimum 5-7 years of experience with environmental monitoring or within the biopharmaceutical industry
• Minimum required training; GxP/GDP Training, Safety Training
• Proficient with computer software such as; Microsoft Office, MODA/LIMS; Microsoft Visio (preferred); Netsuite (preferred); Maximo Asset Management System (preferred)
• Proficient knowledge of ISO and EU standards
• Strong knowledge of quality systems and ability to interpret Quality standards for implementation and review.
• Strong written and oral communication skills
• Strong technical writing skills
• Technical training experience

Must be detail oriented, can multi-task, work in a team environment, and have the flexibility to adapt to company growth as well as its evolving responsibilities. Supervisory Responsibility; Direct reports. While performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens. Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, liquid nitrogen and noise levels. Must have the ability to work in a team-oriented environment and with clients. Must be able to work during the weekend, holidays and as required by the company. Working Environment While performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens. Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen. Other exposures may include gases (nitrogen), or corrosive chemicals (Clorox, potassium hydroxide), or exposure to liquid nitrogen. The noise level in the work environment is moderately noisy. Must have the ability to work in a team-oriented environment and with clients. Must be able to work during the weekend, holidays and as required by the company. Must be able to handle the standard/moderate noise of the manufacturing facility. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.