QC Equipment Specialist

Thermo Fisher Scientific | Posted 5-11-2020

Swindon ()

When you’re part of Thermo Fisher Scientific, you’ll do challenging work, and be part of a team that values performance, quality and innovation. With revenues of $24 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.
At our site in Swindon, Thermo Fisher are forging partnerships that are transforming the industry, creating new business models between pharma companies and their pharma service providers. We are pioneering solutions that are driven by client needs.
The job:
This role requires you to operate within a matrix management system to deliver key responsibilities. You will be accountable for timely and complaint calibration and qualification of Laboratory Equipment (URS/DQ/IQ/OQ/PQ) within Quality Control.
What will you do?

  • To lead, plan, coordinate and execute timely calibration and qualification of all QC laboratory equipment across the QC labs ensuring equipment is kept in a state of control and compliance
  • Ensure QC equipment calibration and qualification activities are planned, effectively tracked, monitored and achieved in accordance with agreed timelines
  • Writing & execution of protocols and reports (URS/DQ/IQ/OQ/PQ), organisation of qualification work into packages suitable for audit presentation
  • Completing routine performance checks and calibration duties on analytical laboratory equipment as specified in the calibration schedule
  • Maintain and control a visual management system of qualification, validation and calibration activities
  • Assisting in maintaining a clean working environment within the QC Laboratory
  • Collaborate and coordinate initiatives with other QC Supervisors and Mangers
  • Regularly generate and provide detailed update reports for Quality and Site management
  • Generate and prepare quality documents e.g. SOP’s and controlled documents
  • Lead and/or support investigations into issue impacting analytical equipment
  • Review & approve deviation and any change proposals related to analytical equipment issues
  • Act as SME for the above with regulators / clients (i.e. key part of audits and inspections)
  • Ensure own KPI actions, plans, targets and objectives are effectively tracked, monitored and achieved in accordance with timelines
  • Ensure own work complies with GMP, Data Integrity and Good Documentation Practice (GDP) and is undertaken in accordance with applicable quality documents e.g. SOP’s, analytical methods, Protocols, Guidance’s, etc.
  • Ensure own training is undertaken in a timely and GMP compliant manner before the task is undertaken
  • Identify and drive Practical Process Improvement initiatives (PPI)
  • Undertake/support Self-inspections, GEMBA walks and Huddle meetings as relevant
  • Undertake ad-hoc activities that may be required by the business
  • Support and encourage a “Quality Culture” and company 4i values throughout QC

Who are we looking for?
  • Relevant science-based degree; e.g. Chemistry, Biology, Pharmacy
  • Substantial experience working in a pharmaceutical QC function, preferably within a sterile site
  • Substantial Technical experience, and ‘hands-on’ knowledge working with calibration and qualification of analytical systems such as balances, HPLC, GC, Chromatography Data System (CDS) such as Waters Empower software, UV, IR with the ability to maintain & troubleshoot these systems
  • Extensive experience of instrumental and traditional analytical techniques
  • Communication skills – must be able to speak, listen, and write. Hold presentations, facilitate meetings and trainings, and create reports
  • Good Collaboration and Conflict resolution skills
  • Good technical writing skills
  • Wants to learn and have a natural curiosity to understand systems and processes
  • Ability to work in a fast-paced environment essential

What’s in it for you:
  • Competitive base salary
  • Annual bonus
  • Free on-site car parking
  • Contributory Pension
  • Private medical insurance
  • Flexible benefits

About us:
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them.
Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon
With Thermo Fisher Scientific, it’s not just a career. It’s a chance to realise your best – professionally and personally.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Apply today! http://jobs.thermofisher.com