QA Officer
2 months ago
As the QA Officer you will report directly to the QA Manager based at our site in Cramlington, Northumberland. This is a site-based role, working Monday-Friday dayshift.
Working as part of our onsite Quality team, the main purpose of your role will be to perform batch sentencing activities on a named set of products and all quality assurance activities including reviews and approvals etc relating to those products, working in accordance with current Good Manufacturing Practice (cGMP) and regulatory standards.
Please note that we are not able to offer sponsorship for this role therefore applications outside of the UK will not be considered.
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
- Processing controlled intermediates and finished goods within a specified time frame as outlined in written procedures. These cover production and analytical review, deviation and non-conformance.
- Carrying out SAP transactions in an accurate and timely manner.
- Reviewing and approving Change Control and temporary instructions using Master Control.
- Collaborating with internal stakeholders to address quality-related matters and ensure effective communication.
- Complying with all safety, health and environmental requirements.
- Reviewing and releasing of raw materials.
- Completing deviation investigations using Master Control and assisting with data gathering for stakeholders within the business.
- Conducting visual inspections of plant equipment and pre-start up audits on plant.
- Embodying our company values; Be Transparent, Be Willing, Be Reliable and Be Caring.
- Qualifications related to this role would be beneficial (e.g. Chemistry or Quality related discipline).
- Must have a working knowledge of cGMP requirements and guidelines.
- Previous pharmaceutical experience is essential, ideally within Active Pharmaceutical Ingredient (API) manufacturing.
- Must be an effective communicator and able to communicate at all levels.
- Knowledge of quality assurance, laboratory practices and production is necessary.
- 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.
Be caring. Be transparent. Be willing. Be reliable.
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