Senior Quality Control Operative

The Newcastle upon Tyne Hospitals NHS Foundation Trust

An exciting opportunity has arisen for a talented individual to take on the role of Senior Quality Control Operative. The candidate will be working within a small Quality Control Laboratory based within the Pharmacy Production Unit at the Royal Victoria Infirmary, supporting other members of the Quality Control Laboratory who are releasing officers for the (Medicines and Healthcare Regulatory Agency) MHRA MS17163 licence held by Newcastle Specials for the release of 'Specials' manufactured by the Pharmacy Production Unit. The role is a mix of traditional Quality Control laboratory techniques and also supporting the Pharmaceutical Quality System such as writing QC worksheets, Standard Operating Procedures and other documentation. Good record keeping skills are required. The Quality Control Laboratory has a variety of equipment including HPLC, FTIR, auto titrators, pH meter, conductivity meter, refractometer, melting point etc., full training will be provided. Quality Control laboratory test results are used to support product testing for release for patient use, stability studies to support expiry allocation of current products and also allocation of expiry for new products.

• 37 hours 30 minutes/week

Main duties of the job

The Senior Quality Control Operative will be responsible for undertaking a range of laboratory and other duties necessary to ensure the Pharmaceutical Quality Control service operates in an efficient, safe and effective manner.

Duties will include managing samples sent off site to contact laboratory and the handling of results, managing laboratory stock levels and ensuring orders are raised and correctly processed on receipt. Required to be involved with the processing, sampling and testing of certain defined products, having successfully completed the in-house competency based training programme that encompasses the concepts of Quality Assurance, Good Manufacturing Practice (GMP) and Quality Control.

Suitable candidates should possess and state on their application a GCSE (Minimum Grade 4 or equivalent) in Mathematics, a Science based subject and English Language or previous relevant experience.

Job responsibilities

• To carry out the full range of duties including receipt, processing, sampling and testing of raw materials, packaging materials and certain defined products, having successfully completed the in-house competency based training programme that encompasses the concepts of Quality Assurance, GMP and Quality Control.
• To liaise with external organisations to source certification for raw materials and packaging materials.
• Assist in the product releasing process by transferring released items from quarantine to the Production Store.
• To send samples off site to a contract laboratory ensuring all documentation is completed. To receive completed results and file appropriately.
• Assist in the inputting of environmental monitoring results into the database.
• To maintain stock levels of analytical reagents and chemicals in the QC Lab.
• To prepare orders, check all analytical reagents and chemicals on receipt and ensure they are correctly stored and documentation processes completed.
• To ensure that used laboratory glassware is cleaned, dried, and returned to the appropriate storage thus avoiding cross contamination and the invalidation of analytical results.
• Assist the Trust Quality Controller and other QC/QA staff by photocopying and distributing approved copies of authorised documentation.
• Assists in the training of rotational staff assigned to the QC Laboratory.
• Storage and organisation of reference samples and destruction when appropriate.
• Complete the daily equipment checks.

Please note it is a requirement of The Newcastle upon Tyne Hospitals NHS Foundation Trust that all successful candidates who require a DBS for the post they have been offered pay for their DBS certificate. The method of payment is a salary deduction from your first months pay.

As a flexible working friendly organisation, we want to be sure that you can work in a way that is best for us and for our patients, and for you. Speak to us about how we might be able to accommodate a flexible working arrangement. If it works for the service, we will do our best to make it work for you.

Person Specification

KNOWLEDGE

• Demonstrate knowledge and understanding of the duties carried out within the role.
• Understanding and appreciation of Chemistry.
• An understanding of some of the hazards associated with handling solid and liquid chemicals.
• Knowledge of GLP (Good Laboratory Practice) or GMP (Good Manufacturing Practice).
• Working knowledge of Microsoft computer systems.

SKILLS

• Good organisational skills.
• Good oral communication.
• Ability to maintain high level of accuracy in a busy environment.
• Capable of working with minimum supervision.

EXPERIENCE

• Previous experience of GLP or GMP.
• Competence in the undertaking and organisation of delegated tasks associated with ordering and receipt of chemicals and reagents and distribution of approved documentation.

QUALIFICATIONS

• GCSE (Minimum Grade 4) in Maths, a Science based subject and English Language or equivalent qualification or previous relevant experience.
• A Level Chemistry or equivalent qualification.

Disclosure and Barring Service Check

This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.