Quality Control Bioassay 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.

Summary:

We are seeking a highly skilled and motivated Quality
Control Bioassay Specialist to join our Quality Control team on a fixed -term
contract basis .This critical role will support key bioassay laboratory
start -up activities and provide technical expertise to support quality control
testing, method troubleshooting, method establishment, investigations, and
capability building across the team.

The successful candidate will play an important role in
helping establish the laboratories as a hub for specialised analytical testing,
while ensuring compliance with cGMP and corporate regulations. This is a
high -impact role within the Quality organisation, offering the opportunity to
contribute directly to operational excellence and patient impact.

Requirements

Key Responsibilities:

• Provide technical support for Quality Control testing
  activities, including:
  
• Method execution troubleshooting
  
• Method establishment
  
• Input into investigations
  
• Capability building in Biochemistry, Cell Biology, and
  Analytical methods
  
• Support the performance and optimisation of advanced
  assays requiring strong analytical and scientific understanding.
  
• Review, evaluate, and approve analytical testing data.
  
• Complete special project and protocol testing in a timely
  manner under direction of Project Leads and/or Area Leads.
  
• Use laboratory instrumentation and Global LIMS or other
  computerized systems to collect, record, and approve test data/results.
  
• Collaborate with laboratory and cross -functional teams to
  improve efficiency, solve problems, generate cost savings, and support new
  product introductions.
  
• Operate with minimal supervision and demonstrate sound
  judgment and accountability.
  
• Maintain the laboratory in a GMP -compliant state in
  accordance with EHS and 5S requirements.
  
• Prepare and update SOPs as required.
  
• Apply Lean principles, including 5S, simplification, and
  standard work, in daily activities.
  
• Ensure training requirements are current and support the
  training of others as needed.
  
• Coach and develop team members to build technical
  capability and support a high -performance culture.
  
• Support regulatory submissions, inspection readiness,
  health authority inspections, and responses to inspection observations.
  
• Contribute to audit readiness, laboratory equipment
  qualification, and analytical method transfer, verification, and validation.
  
• Support site metrics and KPI achievement, implementing
  countermeasures where required.
  
• Maintain data integrity and ensure compliance with
  company SOPs, specifications, FDA, cGMP, and other applicable regulations.
  
• Participate actively in inspections, GEMBAs, and Go -Sees.
  
• Promote a strong safety culture by identifying hazards,
  conducting risk assessments, and supporting continuous improvement in EHS
  practices.
  
• Act as a visible leader in safety, quality, and
  continuous improvement initiatives.
  
• Encourage innovation, problem solving, and real -time
  data -driven decision -making to improve the value stream.
  
• Perform other tasks as required.
  

What You’ll Bring:

• Degree in Science, Quality, or a related technical
  discipline.
  
• Minimum of 5 years’ experience in the biotechnology
  and/or pharmaceutical industry, preferably both.
  
• Strong technical knowledge of cell -based and cell biology
  methods, such as qPCR, as well as analytical methodologies.
  
• Strong understanding of GMP, ICH, USP, and global
  compendia regulations and guidance, particularly relating to analytical method
  development and validation.