Senior QC Analyst Analytical 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.

Job Purpose

• The Senior QC Analyst will be part of the Quality Control
  Testing Hub within a state-of-the-art single-use, multi-product biologics
  facility in Dunboyne, County Meath, Ireland. The role will support laboratory
  start-up activities and routine Quality Control testing, ensuring compliance
  with cGMP, corporate procedures, legal requirements, quality guidelines, and
  market authorisation requirements.
  
• The QC Senior Analyst will work across site self-directed
  work teams and hub teams to identify and resolve issues, support operational
  readiness, and contribute to Quality, EHS, Learning, and Continuous Improvement
  objectives. The role will involve biological, chemical, and physical analysis
  using state-of-the-art laboratory instrumentation and computerised systems.
  
• The successful candidate will have strong analytical
  laboratory experience within the biopharmaceutical industry, including UPLC,
  Capillary Electrophoresis (CE), PA800, deviations, compliance, and raw
  materials testing. The role will also support stability testing, drug substance
  testing, and validation activities.
  

Requirements

Key Responsibilities

• Support the Quality Control testing function and ensure
  compliance with cGMP, corporate procedures, legal requirements, quality
  guidelines, and market authorisation requirements.
  
• Responsible for the release of incoming goods, outsourced
  production and packaging products, and products and processes in accordance
  with established quality procedures and regulatory requirements.
  
• Conduct and support biological, chemical, and physical
  analyses using laboratory instrumentation and computerised systems.
  
• Perform analytical testing associated with UPLC,
  Capillary Electrophoresis (CE), PA800, and other applicable analytical methods.
  
• Support stability testing, drug substance testing, and
  validation activities.
  
• Review analytical data, documentation, and results to
  support the quality release of materials and products.
  
• Support deviation investigations, compliance activities,
  troubleshooting, and problem-solving within the laboratory.
  
• Provide advice on and support improvements to
  quality-related issues to ensure optimal quality of released products and
  processes.
  
• Understand quality requirements for the introduction of
  materials to site and communicate these requirements effectively to suppliers
  and relevant stakeholders.
  
• Apply Good Documentation Practices (GDP) and support
  implementation of documentation requirements at a local level.
  
• Support laboratory start-up, operational readiness, and
  continuous improvement activities.
  
• Work with moderate work direction while demonstrating the
  technical skills, knowledge, and independence required for the position.
  
• Identify and communicate quality and compliance risks
  within areas of responsibility and across the site.
  
• Create and implement strategies and plans to manage risk
  within Quality Control operations.
  
• Collaborate with Manufacturing Operations, Process
  Development Technical Services (PDTS), Quality, suppliers, and other
  cross-functional teams to deliver site objectives.
  
• Support product quality decisions by providing accurate
  and timely analytical information to relevant Quality stakeholders.
  
• Demonstrate strong project management skills and deliver
  activities within agreed timelines.
  
• Work effectively across self-directed work teams and hub
  teams to identify, investigate, and resolve complex issues.
  
• Support a culture of continuous improvement through the
  use of Lean and process improvement tools.
  
• Coach and mentor colleagues and self-directed work teams
  through complex problem-solving activities.
  
• Promote a culture of quality, safety, diversity, and
  inclusion.
  
• Demonstrate flexibility, self-motivation, and the ability
  to work both independently and as part of a team.
  

Key Accountabilities:

• Strong project management and stakeholder management
  skills.
  
• Proven ability to deliver against tight timelines and
  manage multiple priorities.
  
• Excellent influencing, collaboration, communication, and
  teamwork skills.
  
• Strong troubleshooting, investigation, and
  problem-solving capabilities.
  
• Ability to challenge the status quo and demonstrate a
  continuous improvement mindset.
  
• Ability to think logically and proactively under
  pressure.
  
• Experience using Lean Six Sigma and other continuous
  improvement tools.
  
• Ability to support change management and act as a change
  agent within the organisation.
  
• Proven ability to work cross-functionally, meet and track
  schedules, and operate effectively within an interdependent work culture.
  
• Ability to establish stretch goals and support
  self-directed work teams in delivering their priorities.
  
• Demonstrated ability to give and receive constructive
  feedback.
  
• Excellent written and verbal communication skills.
  
• Strong organisational and time-management skills,
  including the ability to escalate issues appropriately.
  
• Commitment to maintaining high standards of quality,
  compliance, safety, and documentation.
  
• Educational & Experience Requirements
  
• Degree qualification in Science, Technical, Quality,
  Chemistry, Biology, Pharmaceutical Science, or a related discipline.
  
• Minimum 4 years of relevant experience in the
  biotechnology and/or pharmaceutical industry.
  
• No graduate-level candidates; relevant industry
  experience is required.
  
• Strong experience within a biopharmaceutical Quality
  Control/Analytical Laboratory environment.
  
• Experience with UPLC, Capillary Electrophoresis (CE), and
  PA800.
  
• Experience with raw materials testing and release.
  
• Experience with deviations, investigations, compliance,
  and quality systems.
  
• Experience supporting stability testing, drug substance
  testing, and analytical validation activities.
  
• Understanding of cGMP requirements for laboratory
  operations, systems, and compliance.
  
• Understanding of GMP, ICH, USP, and global compendial
  regulations and guidance.
  
• Demonstrated understanding of continuous quality/process
  improvement tools, such as DMAIC, Lean, 5S, etc.
  
• Proven ability to work cross-functionally and deliver
  against schedules and priorities.
  
• Excellent written and oral communication skills.
  
• Excellent time management and organisational skills.
  
• Ability to work independently with moderate direction as
  well as effectively within a team environment.
  

Other Job Requirements:

• Onsite role based in Dunboyne, County Meath, Ireland.
  
• The successful candidate will work as part of a Quality
  Control team of approximately 28 people.
  
• This is a critical role within the Quality organisation
  supporting the establishment of the laboratory as a hub for specialised
  analytical testing and delivering value for patients.
  
• The role requires flexibility and the ability to work
  effectively within a fast-paced, start-up/multi-product biopharmaceutical
  manufacturing environment.