QC Senior Analyst

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:

• The QC Senior Analyst works as directed by the QC
  Manager/QC Associate Director according to company safety policies, cGMP and
  cGLP. Ensure that QC team objectives are effectively achieved, consistent
  with  requirements to ensure compliance,
  safety and reliable supply to our customers.
  
• Essential Functions and Responsibilities (Includes, but
  are not limited to) The QC Senior Analyst, is responsible for:
  
• Operating as part of the QC team performing the allocated
  testing and laboratory-based duties.
  
• Act as testing SME with QC department, participate in OOS
  investigations and supporting troubleshooting activities.
  
• Participate in QC Tier daily meetings and ensure
  effective communication of testing progress, deviations, escalation of
  potential cGMP or compliance issues etc.
  
• Participate in writing/revising/ rolling out accurate
  operational procedures, training materials and maintenance procedures for
  various Quality systems.
  
• Peer review of testing documentation and ensuring data
  integrity compliance and QC Right First Time KPIs are achieved.
  
• Support activities including general lab readiness, audit
  readiness and audit participation, laboratory equipment qualification and
  analytical method technical transfer, verification and validation.
  
• Candidate might be required to go on shifts, yet to
  confirm. (It is 7 to 7 shift cycle)
  

Requirements

Responsibilities:

• Contributing to a continuous improvement environment and
  bringing problem solving and troubleshooting capabilities.
  
• Demonstrating a commitment to learning and personal
  development
  

Minimum Education/Experience:

• Degree qualification (Science/Quality/Technical or
  related)
  
• Laboratory experience, including sampling, testing,
  reporting in the biotechnology and/or pharmaceutical industry.
  
• 2-3 years of experience in QC Microbiology
  
• Knowledge about EM, Water Monitoring, Endotoxin Testing,
  Bioburden Testing
  

General competencies:

• Motivation to be an inspiring member of a high performing
  team and passion to build the future
  
• Desire to continuously learn, improve and develop.
  
• Flexible and self-motivated.
  
• Required to work on their own initiative in addition to
  working as part of a team.
  
• Ability to manage multiple priorities and know when to
  escalate issues for resolution.
  
• Excellent time management and organizational skills.
  

Technical:

• Possess effective communication and presentation skills.
  
• Proficient with IT e.g. Microsoft office.
  
• Good critical thinking and problem solving skills.
  
• Good knowledge of cGMP, GLP, Quality Management Systems.