QC Lead 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,
  manufactures and tests biggest selling biologic and the biggest selling vaccine
  product and is a strategic manufacturing site.
  
• The QC Lead Analyst 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. The
  team works a 2-cycle shift pattern.
  
• Occasional travel may be required for training purposes.
  
• The ideal candidate will have 4+ year’s experience in a
  pharmaceutical laboratory, ideally with experience in ELISA/HPLC/Compendial
  Testing and relevant systems and software. Core to the role is to perform
  testing of samples to support the release of our key drug products.
  
  

Requirements

What you will do:

• 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 review
  
• Perform various analytical techniques including but not
  limited ELISA/HPLC/Compendial Assays in compliance with GMP requirements
  
• Peer review testing documentation and ensuring data
  integrity compliance and QC Right First Time KPIs are achieved
  
• 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
  

What skills you will need:

• Bachelors Degree or higher preferred; ideally in
  Analytical Chemistry/ Biochemistry or a closely related discipline
  
• 4+ years of experience in a pharmaceutical laboratory
  
• A good working knowledge of HPLC systems and software is
  desirable
  
• A good working knowledge of ELISA and Softmax Pro
  software is desirable
  
• A good knowledge of cGMP, GLP, Quality Management Systems