QC Associate Microbiology Specialist

About PSC Biotech

Who are we

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 cloud-based 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 like-minded 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 diverse-cultural work setting.

Employee Value Proposition

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

Overview:

A fantastic opportunity has arisen for a QC Associate Microbiology Specialist.

You will provide technical support to the QC Microbiology Lab & operations to ensure the continued manufacture and supply of quality pharmaceutical products in meeting the priorities of: Compliance Supply Strategy and Profit Plan. This role holds more senior responsibilities within the Microbiology Laboratory including (but not limited to) documentation development report writing execution of method and equipment validation drug product result authorization providing microbiological support for site performance of bench experiments as required.

You will be capable of self-management and decision making and will demonstrate a high level of leadership initiative collaboration and coaching to facilitate the team in becoming a high-performance organization. Central to this objective will be the active engagement and communication with all internal (e.g. QC Analytical Tech Ops IPT QA) and external (e.g. Microbiology COE). A high level of innovation enthusiasm and drive will be required to deliver technical excellence is required for this role.

Requirements

Role Functions:

• Development and execution of Microbiology test methods and project validations.
  
• Troubleshooting of issues which arise during the execution of validation studies and routine tests.
  
• Development of training modules.
  
• Microbiology Support to Site Investigations
  
• Driving Continuous Improvement initiatives including lean lab initiatives method optimization/redevelopment.
  
• Authoring and managing change controls procedures test methods and deviations.
  
• Result authorization for microbiological samples to support batch release.
  
• LIMS System updates
  
• Assessing compendial and quality manual updates pertaining to the Microbiology Lab & environmental control.
  
• Supporting lab stock management and financial control as required.
  
• Supporting the environmental control program by trend analysis and implementation of appropriate corrective and preventative measures.
  
• Understands and applies regulatory / compliance and compendial requirements to their role together with remaining current on upcoming regulatory and compliance changes.
  
• Interprets customer needs assesses requirements and identifies solutions to non-standard requests.
  
• Makes decisions within guidelines and policies which impact microbiology projects.
  
• Ensures highest safety standards.
  
• May be required to perform other duties as assigned.
  

Experience Knowledge & Skills:

• Strong Planning and Organising skills
  
• In-depth knowledge of the veterinary market
  
• In depth knowledge of pharmacovigilance legislation and guidelines
  
• Wide-ranging and sound communication skills
  
• Ability to work well within in a high performance team structure
  
• Ability to work under pressure to deadlines
  
• Sound interpersonal skills for dealing with a wide range of people in a variety of situations
  
• Ability to communicate (verbally and in writing) clearly and succinctly
  
• Self-starter with drive and focus
  
• Sound commercial acumen with high levels of integrity and trustworthiness
  
• Good presentation skills
  
• Sound IT and software skills
  
• Passion and persistence
  

Qualifications & Education:

• In order to excel in this role you will more than likely have:
  
• Bachelors Degree or higher preferred; ideally in Microbiology or a closely related discipline.
  
• Demonstrated change management skills (CEM) with continuous improvement.
  
• Strong knowledge in execution validation and development of microbiology related test methods i.e. Bioburden Endotoxin and Sterility testing.
  
• At least 5 years experience in the Microbiology Pharmaceutical industry or a similar operating environment.