<p>Kedrion Biopharma has a new opportunity for a Quality Assurance Associate to join the Quality department located in Elstree, Hertfordshire. This exciting role will give you the chance to develop your skill-set and grow your career within Quality where you will work closely with the manufacturing team on the “shop floor” and build relationships across departments.</p><p>Ensuring timely completion of accurate batch records and making sure they align with scheduled operations, the role will also involve reviewing and auditing manufacturing batch records to guarantee compliance with procedures, policies, and cGMP standards for QP disposition. Responsibilities also include compiling reviewed batch records, collaborating with QPs on batch disposition determinations, and aiding in the initiation and management of deviation and CAPA records.</p><p>Kedrion Biopharma is a biopharmaceutical company headquartered in Italy, which collects and fractionates blood plasma to produce and distribute worldwide plasma-derived therapies for use in treating and preventing serious diseases, disorders, and conditions.</p><p><strong>This role is on a 24/7 shift - 4 days on, 4 off, 4 nights on, 4 off - 12 hour shifts - 7am - 7pm and 7pm to 7am</strong></p><p><strong>Our site is not easily accessible by public transport so please take this into consideration when applying as this role is fully on-site.</strong></p><p><strong>Duties & Responsibilities –</strong></p><ul><li>Participate in daily updates for batch release priority</li><li>To initiate and assist with deviations and changes related to batch review and be able to assess them on behalf of the QP. </li><li>Complete GMP reviews of batch documents in a timely manner in keeping with manufacturing schedules.</li><li>Highlight significant GMP and patient safety concerns to supervisor or QP’ as needed. </li><li>To co-ordinate and maintain the files for a range of quality records as required. </li><li>To participate as required in Regulatory and customer audits.</li><li>To assist in progression of regulatory actions, customer complaints, GDP incidents where required. 8. To perform regular audits of the manufacturing facility and contribute to continuous improvement activities. </li><li>To undertake work related to job objectives as directed by QA management</li></ul><p><strong>Skills & Education required to help you within the role – </strong></p><ul> <li>Education</li> <ul> <li>Degree level qualification in science discipline or equivalent.</li> </ul></ul><ul> <li>Skills and Experience</li> <ul> <li>Experience of working within a (bio) pharmaceutical, clean room or manufacturing environment.</li> <li>Knowledge of sterile aseptic filling and packing manufacturing processes is desirable.</li> <li>The job holder is expected to demonstrate a willingness to engage in self-directed learning, an ability to assimilate new information into their routine working practices and a desire to develop their level of experience and expertise.</li> <li>Experience of working with documentation and quality management systems desirable.</li> <li>A natural tendency towards continuous improvement is required. </li> <li>Experience with blood products is desirable but not essential.</li> </ul></ul><p>We're looking for highly motivated and experienced people to drive the business forward. If you are passionate about quality and want to work within a reputable pharmaceutical company, then we want to hear from you. </p><p><strong>In return we offer -</strong></p><ul><li>Competitive salary</li></ul><ul><li> Annual bonus scheme</li></ul><ul><li> 25 days holiday (plus bank holidays)</li></ul><ul><li> Pension</li></ul><ul><li> Life insurance</li></ul><ul><li> On-site parking</li></ul><ul><li> Employee assistance programme </li></ul><ul><li> Virtual GP </li></ul><ul><li> Cycle to work scheme</li></ul><ul><li> Subsidised canteen</li></ul><ul><li> Employee discounts and cash back</li></ul><ul><li> Gym membership discounts</li></ul><ul><li> Family friendly policies</li></ul><ul><li> Employee recognition programme </li></ul><ul><li> Loyal service awards </li></ul><p>In 2022, Kedrion joined forces with BPL (Bio Products Laboratory). Based in Elstree, BPL operates a targeted portfolio of successful plasma-derived products to treat rare diseases. There are nearly 1000 colleagues based at the campus, where a number of our life-enhancing plasma-derived products are manufactured. </p><p>With the combination of Kedrion and BPL, the company now becomes a global player in plasma derivatives and rare disease medicines employing more than 4,800 people worldwide. As a joint company, we function as a bridge between donors and the people who need treatment, and work on a global scale to expand patient access to plasma-derived therapies. </p><p>Please apply today for immediate consideration.</p> •
Last updated on Jan 31, 2025