Senior QC Analyst

Full Time
Technical Role
North East England

Duties & Responsibilities

Perform testing and reporting on finished products in line with established procedures to ensure product release and regulatory compliance. Support the QC Supervisor and provide deputy cover when required:

  • Check and approve completed QC documentation, including QCI’s and CoA’s
  • Monitor the status of ongoing batches and general lab organization. 
  • Complete final checks on real-time documents.
  • Assist in planning and prioritising work for the QC department. 
  • Perform internal audits when trained accordingly. 
  • Communicate with external stakeholders.
  • Complete and upload purchase requisition forms to QMS.
  • Prepare training and train other members of staff.
  • Analyse products in accordance with approved methods and in compliance with ISO 13485 requirements.
  • Complete documentation to ensure all activities are recorded to meet customer and regulatory requirements.
  • Carry out in-process tests.
  • Ensure that safe working practices and conditions are maintained within the laboratory.
  • Perform calibration/calibration checks of laboratory equipment as per relevant procedures.
  • Assist in the production of SOP's, Quality Control Instructions and Spreadsheets related to testing specifications, laboratory equipment and/or quality related activities as required.
  • Raising and completing change orders and non-conformances.
  • Measure/test incoming goods/material in accordance with Material Specifications (MS), Purchasing, Receiving and Incoming Goods Inspection and Supplier Evaluation SOP or other applicable documents, compare documentation for Incoming goods/material with MS and perform all tasks required for Incoming Inspection.
  • Communicate with SQE, QA, Supply chain, Warehouse regarding activities relevant to Incoming Inspection
  • Monitor performance by gathering relevant data and producing statistical reports.
  • Liaise regularly with other departments to ensure the company maintains its high-quality standards.
  • Always observe confidentiality.
  • Carry out packaging checks on finished products.
  • Adhere to all Health and Safety/COSHH requirements as directed.

Requirements

  • Educated to degree level, with a minimum of three years' experience in a laboratory environment.
  • Competent in the use of standard office and spreadsheet software.
  • Able to prioritise and manage work effectively to meet set timescales.

 

 

 

 

Location
Hart Biologicals Limited
2 Rivergreen Business Centre
Queens Meadow
Hartlepool
TS25 2DL