Laboratory Analyst

Basic qualifications: 

• Completed HNC or equivalent qualification in a relevant scientific discipline.  Alternatively, will have relevant professional knowledge and experience

Preferred qualifications: 

• Is proficient in the use of numerous Laboratory instruments, software packages and other analytical techniques.

Details: 

We are a science-led global healthcare company that researches and develops a broad range of innovative medicines and brands. Our products are used by millions of people around the world, helping them to do more, feel better and live longer. Employing close to 100,000 people globally, we have 87 manufacturing sites around the world.

Our pharmaceuticals business researches, develops and makes available medicines that treat a variety of serious and chronic diseases. We have medicines available or in development in a wide range of areas including:

• infectious diseases 
• cancer 
• epilepsy 
• heart disease 
• asthma and chronic obstructive pulmonary disease 
• HIV/AIDS 

Ware Manufacturing Site:

Medicines at Ware are presented as either Respiratory devices or in Oral Solid Dose form. The site holds a unique position in our network as the only site responsible for launching the company’s pipeline of new medicines in these dose forms, many of which are life saving medicines. A series of investments in new state-of-the-art equipment are being made that will support the delivery of a record number of new products. This must be achieved whilst consistently delivering outstanding quality, service and value to our patients.

Job purpose:

The Quality Assurance Department independently ensures that all aspects of the manufacture of products are performed in a controlled manner and meet commitments to international regulatory bodies as well as the requirements of current Good Manufacturing Practice.  The laboratories, working as part of the Site Value Streams, will assure that manufactured products are compliant and fit for purpose.    

Kay accountability:

• Performs analysis of samples and supports technical investigations/ monitoring, using a range of analytical techniques including chromatography, pharmacopoeial and physical property tests.
• Prepares and checks analytical data accurately according to company, customer and regulatory requirements.
• Assesses the quality and accuracy of analytical results and determines if material meets pre-defined acceptance criteria.
• Undertakes analysis as required to support process investigations or as part of process qualification and validation exercises.
• Is responsible for assigned items of Laboratory equipment or 5S standards.
• Is responsible for the safety of self and others within the Laboratory.

Customer 

• Analyses samples according to pre-defined test methods, specifications or Pharmacopoeia.  Ensures analytical records are accurate, clearly laid-out, legible, and recorded at the time of the task.

Cost 

• Is responsible for ensuring that Laboratory work areas maintain high standards of housekeeping and meet requirements such as 5S.
• Responsible for ensuring own work is right first time.
• Responsible for maintenance and calibration of Laboratory equipment as assigned by Team Manager.
• Checks analytical data/worksheets for accuracy and compliance and ensures correct methodology has been used.   
• Ensures documentation associated with own areas of responsibility, such as equipment records, are current and audit ready at all times.
• Responsible for ensuring equipment used is calibrated, validated and fit for use.  Deficiencies are resolved promptly in consultation with the responsible person or expert user.
• Analysis is undertaken safely and compliantly, meeting all required standards of EHS legislation and GMP, such as COSHH, Risk Assessments and DSE.
• Responsible for documenting and communicating Laboratory issues, such as safety, compliance and analytical issues giving rise to invalid data. 
• Ensures sample solutions, standards and test media are used within expiry dates, or re-evaluated as appropriate
• Has awareness of change control processes and need to control changes.

People 

• Takes responsibility for own training and development. Maintains up to date training records, as well as performance and development plans.
• Provides training in areas of expertise, such as the use of analytical equipment to fellow Analysts.
• Proactively provides feedback on the quality and effectiveness of training as it is received.
• Maintains analytical knowledge and access to systems ensuring they are up to date for all relevant equipment and techniques, and seeks refresher training as required.

New Products:

• May participate in method transfers and new product introduction exercises, for example, trialing new technology and methodology, providing feedback to Team Manager and other staff.

Customer 

• Performs analysis to support evaluation of manufacturing processes, in addition to batch release testing.  Tests according to authorised protocols and testing regimes.
• May be required to review and approve batch data within corporate IT systems. 
• Keep up to date records to show status of batch testing.  For example, may maintain planning boards.
• Undertake any additional daily or long term tasks assigned by Team Manager, such as reviewing procedures or report writing.

Cost 

• Supports continuous improvement activities within the Laboratory, regularly identifying areas for improvement in compliance, 5S standards, safety or efficiency and participates in the implementation of changes.
• Is aware of Lean Sigma Tools and principles of Operational Excellence, the Quality Management System and management principals, and relates these to own tasks and objectives.
• Routinely works with little guidance and to a high standard of technical competency.

Compliance

• May be required to write procedures or guidelines for the use of analytical equipment and to describe Laboratory working practices.
• May perform analysis to support method or equipment validation.
• Participates in audits of Laboratory systems, in inspection readiness activities and preparation for external audits.
• Highly competent in identifying and locating correct, relevant documentation and procedures, such as SOPs and LAMs.
• Handles or disposes of hazardous materials safely and in accordance with procedures.

People

• Attends training courses, team meetings and briefings, contributing assertively, completing assigned actions in an agreed timeframe.  Provides feedback on the outcome of any actions and any further learning points.

Problem Solving

• Responsible for identifying Out of Specification and Atypical results and will participate in Laboratory Investigations. Assists Senior Analysts and Team Managers in the design of root causing experiments and retest plans, ensuring investigations are completed in a timely manner and that sound scientific rationale is employed 
• May create documents, such as notifications, to record batch failures or to initiate updates to specifications or test methods.


Skills /experience needed:

• Embraces own errors as an opportunity for improvement, and shares learnings.
• Always contributes positively to team or department.  
• Has a keen eye for detail and is readily able to identify procedural or GMP errors.
• Is able to present information competently to small groups.
• Completed HNC or equivalent qualification in a relevant scientific discipline.  Alternatively, will have relevant professional knowledge and experience.
• Is proficient in the use of numerous Laboratory instruments, software packages and other analytical techniques.
• Is proficient in problem solving and may have expertise in troubleshooting analytical equipment.
• Is competent in application of statistical and mathematical tools and formulae.
• Understands purpose of all techniques applicable to dosage form
• Is aware of relevant national/international Pharmaceutical regulatory authorities.

Closing date for applications: Friday 28th October, 2016

Contact information: 

You may apply for this position online by selecting the Apply now button.