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Job ID :
65537BR
Location :
United Kingdom - Basingstoke
:
Job Description
Job Title: QA Operations Support (QAOS) Supervisor
Location: Basingstoke, Hampshire UK
Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of more than $20 billion and approximately 65,000 employees globally. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics, deliver medicines to market and increase laboratory productivity. Through our premier brands – Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services – we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive services.
Summary:
The QA Operations Support (QAOS) Supervisor will champion and lead the implementation, improvement and continuation of quality assurance practices in Operations. The QAOS Supervisor will lead a team of manufacturing facing quality professionals (in partnership with Operations) and is the primary point of contact for all Quality matters affecting daily operational activities.
The QAOS Supervisor will assist Operations management in facilitating SOP management and procedural adherence, training efficacy, failure and non-conformance investigations, change controls, in process controls and validation. In addition, they will evaluate and recommend process changes to improve the Value Stream performance and regulatory compliance.
The individual selected for this role will act as an effective leader in promoting quality disciplines, decisions and practices and will apply sound, systematic, problem-solving methodologies in identifying, prioritising, communicating and resolving quality issues.
Key Responsibilities:
  • Manage a team of two (2) Quality Engineers.
  • Provide Quality leadership to Operations investigations, deviations, change controls, validation protocols, validation reports, SOPs, and in-process controls.
  • Enable collaborative relationships between Operations and Quality with the overall focus of improving customer satisfaction.
  • Assist Operations in troubleshooting process issues and facilitate inter-department team workshops in the resolution of process issues and quality concerns.
  • Work closely with Operations, R & D, Purchasing and Engineering to improve quality while reducing material scrap and costs.
  • Drive quality management focus on productivity and compliance improvements throughout operations.
  • Partner with Operations leadership to establish controls and inspection points to facilitate detection, correction, and prevention of nonconforming materials, parts, assemblies, and products.
  • Serve as Quality Representative for all quality-related corrective/preventive actions within Operations.
  • Assure that Operation's standards comply with division and departmental policies, national and international codes, and applicable safety requirements.
  • Analyse trends and collaborate with Operations to investigate trends, conduct root cause analysis and implement corrective actions for processes and products.
Minimum Requirements/Qualifications:
  • Bachelor’s degree required in a scientific discipline or related field with significant quality assurance experience in a medical device or pharmaceutical manufacturing environment.
  • Experience of managing and developing a team within a quality environment.
  • Strong background in process control and statistical techniques.
  • Medical device, cGMP, EU Regulation or ISO 13485 background.
  • Demonstrated working knowledge of compliance, quality and scientific principles.
  • Strong oral and written communication skills.
  • Must be a self-starter who can take general concepts and direction and produce desirable results.
  • Ability to prioritise multiple tasks functions effectively in a global, multi-site organisation.
  • Demonstrated ability to work effectively as a member of a cross-functional team and across cross-functional boundaries.
  • Strong working knowledge of quality related tools, such as structured problem solving, FMEA (Failure Mode and Effects Analysis), SPC (Statistical Process Control), DOE (Design of Experiments) and Six Sigma/PPI.
  • Strong working knowledge of various computer software, such as SAP, as well as Microsoft Word, Excel and PowerPoint.
  • Demonstrated application of expertise and specialist knowledge combined with a good understanding of other areas and how they fit together to enhance overall business performance.
  • Knowledge of qualification / validation (process, sterilisation, cleaning, software) requirements.
  • Perform independently without continual direction and exercise considerable latitude in determining technical objectives.
  • May be required to perform other related duties as required and/or assigned.
Non-Negotiable Hiring Criteria:
  • Excellent oral and written communication skills.
  • Strong leadership skills with the ability to challenge, influence, and build consensus.
  • Ability to work both independently and as a team member.
  • Strong quality background and problem analysis and decision-making skills.
  • Capability to identify complex issues and make modifications in line with regulatory standards and quality principles.
  • Continuous improvement mind set


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