QC Bioassay Analyst Quality Operations Laboratory

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:

• Join a supportive, growing team in the analysis of
  Biologics and Vaccines in a state -of -the -art Quality Operations laboratory. Our
  QC group ensures every single material inside our products is manufactured,
  processed, tested, packaged, stored and distributed aligned with our incredibly
  high standards of quality and meets all regulatory requirements.  Partnering across our internal manufacturing
  facilities, external contract manufacturers and suppliers we create an interdependent
  global manufacturing network committed to deliver a compliant, reliable supply
  to customers and patients on time, every time, across the globe.
  
• The QC Analyst (Quality Operations) will report directly
  to the QC Manager and will help us in the expansion of this Laboratory and
  complete analytical method transfers and validation as well as commercial
  testing.
  
• This role follows a 2 cycle shift pattern, alternating
  weekly: 7am - 3pm (week 1), 3pm -11pm (week 2).
  
• Occasional travel may be required for training purposes.
  

Requirements

Bring energy, knowledge, innovation to carry out the
following:

• Work as directed by the Quality Control Manager according
  to Company safety policies, cGMP and cGLP. Required to drive compliance with
  Global policies, procedures and guidelines and regulatory requirements and
  execute Good Manufacturing Practices (cGMP) in the performance of day -to -day
  activities and all applicable job functions
  
• Participate in QC Tier 1 daily meetings and ensure
  effective communication of testing progress, deviations etc
  
• Participate in writing/revising/ rolling out accurate
  operational procedures, training materials and maintenance procedures for
  various Quality systems; ensure all work is carried out in line with same
  
• Operate as part of the QC team performing the allocated
  testing and laboratory -based duties
  
• Perform various analytical techniques including but not
  limited to HPLC, (HIC, CE, IEX, HP -SEC), ELISA, Cell Based Assay, Cell Culture,
  Capillary Electrophoresis and other compendial test methods in compliance with
  GMP requirements
  
• Peer review testing documentation and ensuring data
  integrity compliance and QC Right First Time KPIs are achieved
  
• Ensure timely completion of all assigned data processing
  and reviewing.
  
• Participate in the laboratory aspects of OOS
  investigations
  
• 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.
  
• Drive continuous improvement, perform root cause analysis
  on system failures and substandard equipment performance, using standard tools
  and methods, to resolve machine and system issues e.g., FMEA, Fishbone
  diagrams, 5 why's etc,
  
• Work collaboratively to drive a safe and compliant
  culture on site.
  

What skills you will need:

• Bachelors Degree or higher preferred; ideally in
  Analytical Chemistry/ Biochemistry or a closely related discipline.
  
• The ideal candidate will have 2 - 3 years’ experience in a
  pharmaceutical laboratory, ideally with experience in HPLC / Cell based assays
  and relevant systems and software. Core to the role is to perform testing of
  samples to support the release of our key drug products.
  
• A good working knowledge of Immunoassay, Cell Culture,
  HPLC systems and software is desirable
  
• A good knowledge of cGMP, GLP, Quality Management Systems