Career Opportunities
Quality Control Team Leader
High Force Research is an established CRO/CDMO based in Durham UK. Our core expertise is in chemical research and development, process optimisation, route design, scale-up and high-quality manufacture of niche, low volume, high value materials including GMP manufacture of novel APIs for clinical study. The main area of business is predominantly in the life sciences sector including pharmaceutical, biotech, diagnostics and imaging, however, work also extends into other sectors such as nanoparticles, polymers, paints, semiconductors and fine chemicals.
We are recruiting a QC Team Leader to lead our QC team. As well as routine analysis on raw materials, intermediates and finished products analysis, our QC Department carry out method development, method validation and stability studies. The QC Team Leader will report to the Head of Quality. It is an exciting opportunity for the right person to join the team and really make a difference. You will manage the team to ensure the required throughput of analysis in line with customers’ requirements and ensure that practices are consistent with GMP and Health & Safety regulations.
Knowledge, Skills and Experience Required
(* must have requirements)
• Possess a minimum of a BSc in chemistry (or a chemistry related subject).
• Relevant experience working within the similar organisation within an analytical testing environment, working in accordance with GMP.
• Management experience and an ability to work well with colleagues and encourage team members to reach their full potential.
• In depth method development experience and an aptitude to being able to develop analytical methods from scratch.
• Good written and verbal communication skills, with a high degree of attention to detail.
• Excellent analytical and problem solving skills.
• Ability to communicate and present data to staff, management, and customers.
• A practical knowledge of a wide range of analytical techniques that includes HPLC, GC, UV-Vis, FTIR, NMR and wet chemical analysis.
• Still willing to work at the bench carrying out analysis for a large proportion of the working week.
• Experience of method validation and implementation of analytical methods in accordance with ICH and pharmacopoeial requirements, as required.
• Computer literate with a good knowledge of data integrity.
• Experience of training staff in analytical techniques and methods.
• Understanding of the maintenance and qualification of equipment and able to do so practically.
• Proactive, enthusiastic, with the ability to work efficiently, and able to adapt to a busy working environment.
• Good knowledge of regulatory requirements.
• A good knowledge of risk assessment.
• A PhD in chemistry with a focus on chemical synthesis or prior experience in a similar role.
• An expansive understanding and practical experience across synthetic methodologies.
• An interest in the application of emerging technologies within a contract research setting.
• Experience of gramme scale organic synthesis.
• Experience of taking projects from early development to proof of concept (mg to Kg development).
• A sound knowledge of practical analytical techniques.
• High level of attention to detail and a critical, inquisitive eye to analyse results.
• Previous experience of working in a quality-controlled environment.
• Ability to complete thorough COSHH assessments and work safely in an R&D environment.
• Strong attention to detail and a desire to learn.
• Excellent communication skills, both verbal and written.
• The ability to build and maintain relationships and work well within a team.
• Desire to learn and a “can do” attitude.
• Flexible, adaptable and able to manage change.
• Motivation to deliver success on every project.
• The ability and enthusiasm to solve complex problems: A “never give up” attitude.
• The successful candidate must, by the start of the employment, have permission to work in the UK.
Key Accountabilities – (this list is not exhaustive)
• Oversee the day to day running of the QC laboratory ensuring housekeeping standards are maintained.
• Perform analytical testing as required, especially with regard to method development and validation.
• Follow internal quality management system procedures, with adherence to GMP regulations.
• Coordination and supervision of analytical testing activities within the QC laboratory to ensure deadlines are met.
• Training of new and existing QC staff members to ensure QC staff are competent and confident in job role.
• Review and approval of testing data generated within the QC laboratory.
• Writing, revision and approval of quality documents relating to QC.
• Coordinate with the production department with regard to testing schedules and ensure regular communication to all parties with regard to the status of projects.
• Represent the QC department at internal meetings, with customers and in audits.
• Ensure all equipment is suitable for use; undertake troubleshooting and maintenance on QC equipment.
• Responsible for ensuring that data integrity requirements are met.
• Writing validation protocols and validation reports.
• Approving product specifications using chemical knowledge.
• Identification and evaluation of new analytical techniques, procedures, and ways of working to support both production and customer requirements.
• Coordination of maintenance and improvements to the analytical laboratory and equipment.
• Coordination of analytical testing carried out by 3rd parties, when required.
• Responsible for on-going stability activities according to ICH standards.
• Work closely with the QA department and carry out any other duties required by the Head of Quality to ensure the smooth running of the department.
Place of work: Bowburn, Durham DH6 5PF.
Flexible hours of work: 37.5 hours per week 7.00am/9.00am – 3.00pm/5.00pm but this can change due to the demands of each project.
Benefits:
• Holiday entitlement: 25 days plus 8 bank holidays
• Option to buy back additional holidays after 1 years’ service
• Company Pension Scheme
• Continual Professional Development & Training Support
• Life Assurance/Death in Service Scheme
• Employee Assistance Programme
• Health Screening
• RSC Membership
