QC Systems 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:

The Quality Control (QC) Systems Specialist supports the
QC Laboratory through routine maintenance, troubleshooting and repairs of all
analytical laboratory instruments, in addition to supporting the instrument
lifecycle (installation, qualification, operation, and retirement).

Additionally, the QC Systems Specialist supports the
management of software application such as Empower, LabX and Signals, and any
requests relating to these systems.

The QC Systems Specialist leads continuous improvement of
QC operations, through their QC Systems knowledge and areas of expertise.

The QC Lab System team ensures that QC objectives are
effectively achieved and consistent with requirements to ensure compliance,
safety, and reliable supply to our customers.

This is a 12 Month Contract role.

Requirements

Role Functions:

The QC Maintenance Instrumentation Specialist roles
and responsibilities include but are not limited to the following:

• Responsible for the planned and unplanned maintenance of
  the QC systems and instrumentation, in compliance with up -to -date data
  integrity, regulatory, and industry standards
  
• Responsible for change control process and mechanisms
  required to maintain a state of continued compliance for the QC systems and
  instrumentation.
  
• Serve as site co -ordinator for software applications such
  as Empower, LabX and Signals.
  
• Support the QC department as a Super User and complete
  method requests as required.
  
• Support the QC department for troubleshooting,
  investigations, and deviations as an SME.
  
• Manage deviations, CAPA’s and change control’s related to
  QC systems and instrumentation and team priorities.
  
• Author and revise local SOPs, work instructions, and
  guidelines.
  
• Serve as an SME for regulatory and internal inspections
  and audits.
  
• Motivation to be an inspiring member of a high performing
  team with the desire to continuously learn, improve, and develop.
  

Experience, Knowledge & Skills:

Technical:

• Strong experience with analytical instrument maintenance,
  CSV experience beneficial.
  
• Experience using software applications such as Empower.
  
• Excellent understanding of data integrity compliance
  requirements.
  
• Demonstrated ability to drive complex tasks to
  completion.
  
• Strong organizational, problem -solving, and continuous
  improvement skills.
  

Business:

• Ability to prioritize activities in line with the
  maintenance schedules and business needs.
  
• Ability to maintain the flexibility to react to changing
  business needs and priorities.
  
• Experience and understanding of the change management
  requirements of validated systems and software.
  
• Excellent communication skills both verbal and written.
  

Leadership:

• Ability to handle multiple projects and deliver on
  critical deadlines.
  
• Demonstrated ability to work independently on own
  initiative and manage time.
  
• Demonstrate ability to work with a team and co -ordinate
  work to meet a common goal.
  
• A high level of self -motivation, knowledge, enthusiasm,
  and drive.
  

Qualifications:

• Third level education in a Science or Engineering related
  course of study