Senior Microbiology Specialist

Who we are

PSC Biotech is a leading Biotech Consultancy firm founded in 1996 headquartered in Pomona California USA with Global operations in Ireland India Singapore Australia and the US serving 350 clients in more than 23 countries worldwide. We provide cloudbased software solutions for Quality Management and Regulatory Inspections pharmaceuticals contract manufacturing professionals and metrology services to our clients.

Take your Career to a new Level

PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling point which includes the opportunity to work with the most talented cohort of likeminded professionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diversecultural work setting.

Employee Value Proposition

Employees are the heartbeat of PSC Biotech we provide unparalleled empowering career development though Learning & Development inhouse training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our client s expectations with regards to quality of all scalable and business unit deliverables staying under budget and ensuring timelines for our deliverables are being met.

Job Description

An amazing opportunity has arisen for a Microbiology Senior Technical Specialist. You will organise schedule and coordinate routine daytoday laboratory operations and Microbiology validation activities. Provide technical oversight and supervise laboratory testing/ review activities. Liaise with laboratory customers to ensure customer demands can be met as required. You will provide technical expertise troubleshooting training and support to laboratory technicians and ensure that objectives are effectively achieved consistent with company s requirements to ensure compliance safety and reliable supply to our customers.

Requirements

What you will do:

Bring energy knowledge innovation and leadership to carry out the following:

• Operate as part of selfdirected work team in allocating testing and assigning tasks based on priorities including daily weekly monthly and quarterly tasks. Perform tasks with a high degree of precision and accuracy and ensure others do likewise.
  
• Liaise effectively with external groups such as Manufacturing Tech Ops CQV Plant Engineering and QA to ensure laboratory support is available as required and testing timelines are met.
  
• Ensure adherence to lab testing schedules applying Lean Lab methodology.
  
• Ensures testing/data review are supported and that results are available within lead times to laboratory customers. Anticipated delays should be escalated with proposed solutions for resolution.
  
• Ensures projects are supported and completed as per project timelines. Anticipated delays should be escalated with proposed solutions for resolution.
  
• Author/provide leadership in the Laboratory/Contamination investigations using own initiative and with minimum supervision.
  
• Coach and mentor the Laboratory Team.
  
• Drive Continuous Improvement in the lab including implementation of lean projects.
  
• Work as directed by according to Company safety policies cGMP and cGLP.
  
• Facilitate and drive effective communication to ensure success.
  
• Ensure the Lab Tier/handovers are facilitated and attendance expectations are met.
  
• Provide support with audit/inspection requirements to ensure department compliance/readiness.
  
• Participate in internal and external audits and inspections taking the role of auditee for assigned areas of responsibility.
  

What skills you will need:

In order to excel in this role you will more than likely have:

• Bachelor s Degree or higher preferred; ideally in Microbiology or a closely related discipline.
  
• Strong knowledge in microbiology related lab test method methods e.g. Environmental Monitoring Microbial Identifications Bioburden testing Endotoxin testing Biological Indicator Testing Absence of Contamination Testing (BacT) Growth Promotion/Sterility Testing.
  
• Experience with New Product Introduction and Microbiology Method Validation experience.
  
• Investigation experience.
  
• Demonstrated project work.
  
• Minimum of 8 years experience in the Microbiology Pharmaceutical industry or a similar operating environment.
  

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