Role and Responsibilities

• Drive the implementation of new processes and be involved in QC activities:
  • Incoming Inspection.
  • In-process testing.
  • Raw material and final product release testing.
  • Stability testing.
  • Test method development.
  • Validation activities.
  • Retain management.
  • Data trending.
• Coordination of sample testing at 3rd party Testing Laboratories.
• Responsible for performing analysis on Raw Material, intermediates, in process and final release analysis in accordance with GMP.
• Perform technical review of data generated in laboratory, validation protocols and reports.
• Management of QC Sample Retention.
• Any other responsibilities as required and assigned by the Quality Control Lead, Group Quality Manager or Operations Director from time to time.
• Perform the Quality Control verification of Customer Orders.
• Investigate out of specification or out of trend results utilizing Structured Problem Solving, Root Cause Analysis tools in conjunction with the QC Lead, QA personnel and other relevant departments and to implement effective corrective and preventative actions.
• Provide assistance to the PBC BioMed team in the continuous improvement of the QMS to maintain ISO 13485 and ISO 9001.
• Support the continuous improvement efforts within the facility by participating in quality and performance improvement projects.
• Support the implementation of Customer project activities at PBC BioMed.
• Review and Update Quality System Documentation as required.
• Support QA Activities such as NCR, CAPA, Change Controls.
• Support Supplier qualification as requested.
• Support Audit preparation activities.
• Liaise with suppliers and service providers on quality control related activities.
• Perform all tasks in compliance with company policies and procedures.
• Support Key Projects.
• Provide direct support when required.
• Other duties as assigned

Qualifications and Education Requirements

3rd level science, engineering or medical degree.

• Good planning and organizational skills.
• Good communication (oral and written)

• Hardworking and highly motivating individual, with a good attention to detail.
• Appropriate computer skills.
• Ability to work both independently and as part of a team.
• Ability to work in a dynamic environment, with changing priorities.
• Excellent interpersonal skills, communication skills (written and oral), customer focus (internal and external) and attention to detail

Note: This description reflects essential functions and does not prescribe nor restrict tasks that may be assigned.