QC Analyst

Summary of the QC Analyst role

As the QC Analyst you will perform analysis and related activities of substances and materials in accordance with safety and compliance regulations such as current Good Manufacturing Practice (cGMP). You will be required to maintain accurate records, prepare samples and collaborate effectively with stakeholders.

Reporting directly to the Analytical Coordinator you will be based at our Cramlington site in Northumberland.

Who Are We?

We are a fast-growing global pharmaceutical CDMO (Contract Development and Manufacturing Organisation), with more than 50 years' experience in developing and manufacturing Active Pharmaceutical Ingredients (APIs). We are a proven and trusted partner to some of the world's most innovative biotechs and leading pharmaceutical companies and are widely recognised for our expertise in complex and hazardous chemistry.

We are a dynamic business, employing more than 1300 talented and passionate people in the UK, US and Europe who together support our customers in bringing new medicines to market, improving and saving the lives of patients. We support our customers through the full product lifecycle from pre-clinical development right up to full scale commercial manufacturing and today we are proud to have built a culture of excellence in science and unrivalled service.

Your responsibilities

• Performing analysis and reporting results in accordance with cGMP requirements.
• Supporting R&D Chemists with analysis of process development and investigation samples.
• Optimising analytical methods and implementing testing procedures to support the transfer of new processes into production.
• Investigating analytical deviations and out of specification results with appropriate rigous and contributing to their root cause resolution.
• Organising the calibration and maintenance of analytical laboratory equipment.
• Performing routine auditing of laboratory areas.
• Carrying out SAP transactions in a timely and accurate manner.
• Performing technical transfers between internal and external customers.
• Supporting method validation and cGMP stability programs.
• Characterising reference materials for use in cGMP analysis.
• Developing, evaluating, and preparing analytical methods and SOPs as required.
• Liaising with manufacturing, technical, and operational quality personnel on relevant aspects of compliance and analytical atypicality.
• Embodying our company values; Be Transparent, Be Willing, Be Reliable and Be Caring.

• Must have a degree in Chemistry or other relevant scientific discipline.
• Previous laboratory experience is essential, ideally in a GMP environment.
• Experience and knowledge of HPLC and GC techniques is essential.
• Good verbal and written communication skills.
• Must be flexible and able to manage changing priorities.
• Previous experience with Chromatography Data Systems is essential, preferably Chromeleon.
• Must align to our company values; Be Transparent, Be Willing, Be Reliable and Be Caring.

Our collaborative and empowering culture is unique to us and is what really sets us apart as a business and this is built upon our four core values: Be Transparent, Be Reliable, Be Willing and Be Caring. We also run a variety of programmes across our sites to promote health, wellbeing and work life balance, in addition to supporting causes and charities close to our employees' hearts, encouraging volunteering within the communities we are part of and even arranging socials, through our global social committees, to encourage team building and reward our team's hard work.

At Sterling we promote mutual trust and respect regardless of your nationality, background, feelings, beliefs, gender or age. Our workforce, much like life, is made up of many different people with many different backgrounds, needs and perspectives. This is something we celebrate at Sterling, as it makes Sterling a better place to work and encourages innovation and collaboration.

We offer a competitive compensation and benefits package including bonus, pension scheme, private healthcare, Engagement Hub, cycle to work scheme, death in service coverage, on-site health and wellbeing support including medical consultations and physiotherapy, 24/7 employee assistance programme, employee referral scheme, sports and social club as well as opportunity for training and further career development.