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
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.

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:
  
• Bachelor’s 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.