Quality Control Analyst

Darwin Rhodes

  • Dartford, Kent
  • Permanent
  • Full-time
  • 1 month ago
Role: Quality Control Analyst
Duration: 6 Months
Location: Dartford, UKShift: 3 weeks rotation early 06.00/ late 13.30 / night 21.00 To conduct Quality Control analysis in support of the smooth running of production by testing, in a timely manner, in process controls and composite samples under day to day supervision.
 To perform analysis on analytical samples in accordance with defined analytical methods and Standard Operating Procedures and within timelines as agreed with line management.
 Review, approval and reporting of generated data for QC Release as required by the role.
 To ensure all analysis is conducted in accordance with company GMP and EHS procedures.RESPONSIBILITIES To be able to work in a manner compliant with EH&S:
  • Ensure all tasks are conducted in accordance with defined Risk & COSHH assessments.
  • To keep at all time the laboratory to the required cleanness with the EHS standards
  • To support identification, reporting and implementation of EHS improvement within the QC laboratory via Entropy in alignment with management.
 To have basic knowledge of corporate standards, site policies and procedures
  • To understand and correctly execute written instructions
  • To ensure timely completion of any training in Compliancewire
  • To maintain related responsibilities in compliance with GMP requirements
  • To identify and trigger a laboratory investigation, deviation, CAPA or change control under the supervision of a more senior analyst
 To manage day to day tasks with daily supervision/guidance:
  • To keep up to date with industry/regulatory developments in relation to particle size technology and cleaning verification/validation techniques
  • Perform analytical testing in an accurate, timely and efficient manner, consistent with cGMP requirements. Testing may include, but is not limited to, routine particle size analysis (Malvern Mastersizers, Sympatec), cleaning verification (HPLC), identification testing (FTIR and Raman), method development and validation (including particle size and cleanability assessments), DSC, Light microscopy, SEM, Moisture content (Karl Fisher), method optimisation and trouble-shooting, technology transfer and pharmacopoeia analyses as appropriate
  • To understand basic principles of PSA / HPLC/DSC equipment and methods
  • To swab processing equipment
  • Prepare test methods for analytical testing and cleaning verification analysis.
  • Prepare Standard Operating Procedures (SOP's), including corporate and departmental guidelines.
  • Prepare analytical test reports for submissions to clients or the Company's other departments. These include, but are not limited to, Statement of Results, Certificate of Analysis and Cleaning Certificates, Method Qualification/Validation Protocols, Method Qualification/Validation Reports and Laboratory Technical Transfer Studies.
  • Experience of GMP requirement with regards to Deviation management, out of specification investigation, reporting incidents, out of tolerance and change controls.
  • Ensure that instrumentation used is correctly calibrated and operated in accordance with SOPs or client/manufacturing instructions.
  • Ensure compliance with data integrity requirements of laboratory equipment and software systems.
  • Communicate with the QC Laboratory staff, QC Manager, Operations, QA, client representatives, service providers and equipment vendors as appropriate.
  • Maintain accurate and up-to-date training records.
  • Attend training seminars and sessions related to any of the above-mentioned topics, if applicable.
  • To perform microbiological sampling including generation of sample labels, organizing sample collection and completing sample submission form
For all the above, being able to identify, document related records in a GMP manner and report to QC supervisor any problems with results. To have basic working knowledge of the following IT systems:
  • Client
  • Word
  • Excel
  • Trackwise
  • ComplianceWire
  • Minitab
Competency behavior:
Refer to client Behavior competency levels, especially:
  • Have precise, accurate and clear documentation
  • Understand principles of GMP and know reasons we work to them
  • Show attention to detail in all work
  • Perform work within a reasonable timeframe for the task being undertaken and complete the task
  • Seek help from QC Senior Analyst/QC Supervisor or other more experienced member of the QC team as and when required
  • Have a positive and professional attitude to work
  • Ability to work individually or as part of a team
  • Good timekeeping both for start and finish times as well as breaks
  • Understand and follow the health and safety rules for work within the QC laboratory
  • Self- motivated
Personnel Development:
 To take personal responsibility to ensure you are adequately trained to execute assigned tasks
 To keep to current GMP and EHS standards.Communication Skills:
 Good verbal and written communication skills
 To communicate, at shift hand-over to the QC teams, Shift hand-over
 To provide regular update to line managementEducational Requirements:
 Science graduate or higher with proven experience of laboratory operation in a cGXP environment or extensive industry experience

Darwin Rhodes