Senior Quality Control Scientist
- Newcastle
- £38,871-46,670 per year
- Permanent
- Full-time
- Interview Date Wednesday 15 October 2025
- 37 Hours 30 Minutes/Week
- You will be redirected to Trac to apply for the vacancy. Please expand the job details section and read all of the information before applying for the vacancy.
- Liaises with Pharmacy Production personnel e.g. Operations Manager, production pharmacists, Team Leaders and Specialist Production Technicians also dispensary staff and pharmacy stores staff and on a daily basis.
- Performs checks on ingredients for all laboratory reagents.
- Monitors temperature records to ensure excursions reported immediately to the appropriate member of staff.
- Observing and judging work practices to decide when documentation and procedures require updating.
- Needs to use skills in chemical analysis to develop and validate new methods for product assay and stability as required by local, national and international guidelines.
- Need to interpret the results of any validation work carried out to ensure that they comply with the appropriate protocols and advise the Laboratory Manager accordingly.
- Needs to be able to interpret equipment validation results in order to release equipment into use and produce the appropriate Standard Operating Procedures for final approval by the Laboratory Manager or Trust Quality Controller.
- Needs to be able to interpret and check Suppliers Certificates of Analysis and Certificates of Conformity to ensure compliance with the appropriate Pharmacopoeial Monographs.
- Needs to understand the QC worksheets and related procedures to investigate out of specification results as required by regulatory requirements. To produce hypothesis testing protocols for investigatory work.
- Freeman Hospital
- Royal Victoria Infirmary (RVI)
- Health Innovation Neighbourhood (on the former Newcastle General Hospital and Centre for Ageing and Vitality site)
- Newcastle Dental Hospital
- Newcastle Fertility Centre
- Northern Centre for Cancer Care, North Cumbria
- Northern Genetics Service
- Cramlington Manor Walks
- To undertake the range of laboratory and other duties necessary to ensure the pharmaceutical Quality Control service operates in an efficient, safe and effective manner.
- To operate and maintain a range of equipment to ensure safe and suitable for use. Understanding and following the regulatory requirements for the introduction of new equipment.
- To generate and follow laboratory procedures and worksheets to ensure consistent methodology.
- To undertake the development and validation of stability indicating analytical methods for current and new medicinal products that are manufactured in the Pharmacy Production Unit and for outside companies that we are contracted to perform such work. To plan stability test points and ensure all products are assessed for on-going stability.
- To undertake laboratory investigations in the event of out of specifications in line with current regulatory guidelines. To initiate microbiological investigations in the event of environmental excursions. To generate when required and also be involved in quality control assessment of change controls for the pharmacy production unit and quality control.
- To release Water of Injection in bulk daily following plant and equipment checks.
- The role will lead to the person acting as releasing officer for the MHRA MS17163 licence held by Newcastle Specials for the release of Specials and to deputise for the Laboratory Manager other quality control duties as required following the completion of an appropriate formal training course that will provide the person with the required body of knowledge to undertake the activities associated with being an authorised releasing officer.
- The role may also lead to training and registration as a QC(MGPS), performing tests on medical gases as required under HTM 02.
- To undertake the range of laboratory and other duties necessary to ensure the pharmaceutical Quality Control service operates in an efficient, safe and effective manner.
- To operate and maintain a range of equipment to ensure safe and suitable for use. Understanding and following the regulatory requirements for the introduction of new equipment.
- To generate and follow laboratory procedures and worksheets to ensure consistent methodology.
- To undertake the development and validation of stability indicating analytical methods for current and new medicinal products that are manufactured in the Pharmacy Production Unit and for outside companies that we are contracted to perform such work. To plan stability test points and ensure all products are assessed for on-going stability.
- To undertake laboratory investigations in the event of out of specifications in line with current regulatory guidelines. To initiate microbiological investigations in the event of environmental excursions. To generate when required and also be involved in quality control assessment of change controls for the pharmacy production unit and quality control.
- To release Water of Injection in bulk daily following plant and equipment checks.
- The role will lead to the person acting as releasing officer for the MHRA MS17163 licence held by Newcastle Specials for the release of Specials and to deputise for the Laboratory Manager other quality control duties as required following the completion of an appropriate formal training course that will provide the person with the required body of knowledge to undertake the activities associated with being an authorised releasing officer.
- The role may also lead to training and registration as a QC(MGPS), performing tests on medical gases as required under HTM 02.
- Good working knowledge of organic, inorganic and physical chemistry
- Good knowledge of analytical techniques used in pharmaceutical quality control
- Familiarity with laboratory safety requirements. e.g. HSE, COSHH
- Some knowledge of microbiology, preservatives and sterilisation
- Practical ability to carry out careful and accurate chemical analyses using both traditional and instrumental methods and an awareness of the limitations of different techniques
- Ability to develop new analytical methods
- Good keyboard and general IT skills
- Good communication, interpersonal and organisational skills
- Ability to support the Laboratory Manager in the training of all grades of staff and introducing students into the Quality Control environment
- Proficient in use and maintenance of laboratory instruments including FTIR, UV, HPLC
- Analytical laboratory experience
- Experience in pharmaceutical analysis and/or quality control
- Degree or equivalent in a scientific subject e.g. Chemistry or Pharmacy
- Postgraduate qualification in analytical chemistry or quality control
- Ability to register with the Royal Society of Chemistry or equivalent
- Good working knowledge of organic, inorganic and physical chemistry
- Good knowledge of analytical techniques used in pharmaceutical quality control
- Familiarity with laboratory safety requirements. e.g. HSE, COSHH
- Some knowledge of microbiology, preservatives and sterilisation
- Practical ability to carry out careful and accurate chemical analyses using both traditional and instrumental methods and an awareness of the limitations of different techniques
- Ability to develop new analytical methods
- Good keyboard and general IT skills
- Good communication, interpersonal and organisational skills
- Ability to support the Laboratory Manager in the training of all grades of staff and introducing students into the Quality Control environment
- Proficient in use and maintenance of laboratory instruments including FTIR, UV, HPLC
- Analytical laboratory experience
- Experience in pharmaceutical analysis and/or quality control
- Degree or equivalent in a scientific subject e.g. Chemistry or Pharmacy
- Postgraduate qualification in analytical chemistry or quality control
- Ability to register with the Royal Society of Chemistry or equivalent