Job Description

Kedrion Biopharma is recruiting for a detail-oriented Sterility Assurance Specialist to join our team in Elstree, Hertfordshire.


In this role, you will be responsible for investigating microbiological samples, reviewing data, analysing, generating data review reports, and producing risk assessments. You will also be required to visit the process areas, including aseptic processing facilities, as needed.


The successful candidate will have a background in pharmaceutical, healthcare, biotech, food, cosmetics or similar working within a Quality, Lab or Sterility team.

Our site is not easily accessible by public transport so please take this into consideration when applying as this role is fully on-site.

Duties & Responsibilities -

To promote the importance of sterility assurance and contamination control across Elstree, and act as an ambassador for best practices. To ensure that microbiological and other related contamination is evaluated and investigated. To ensure that corrective and preventative actions are proposed. To input into deviations and other quality records. To ensure data is trended. To present at internal meetings, including data summaries and audit findings. To ensure microbiological data is trended. To participate in new starter induction. To write reports and investigation summaries. To depoy statistical and qualitative analysis. To perform contamination and related audits of manufacturing and laboraory areas.

Skills & Education required to help you within the role -

BSc in relevant subject (or equivalent experience) Knowledge and prior training in microbiology Planning and organisational skills. Capacity to grasp concepts easily. Computer literate - competent in the use of Microsoft Office, in particular Word and Excel at an intermediate level. Able to communicate clearly and persuasively with the team. Able to motivate others to meet tight deadlines. Work in a logical and systematic manner. Presentation skills, for delivering courses to small (1-5) groups. Strong interpersonal skills; the ability to interact effectively with all levels within the organization, external third parties, and regulatory authorities. Good knowledge/understanding of GMDP. Experience of raising, completing, and investigating quality records. Project management experience. Knowledge of industry guidelines. Experience of writing protocols and reports

In return we offer -

If you are passionate about sterility assurance and have the skills and experience we are looking for, we would love to hear from you.


Competitive salary Annual bonus scheme 25 days holiday (plus bank holidays) Pension Life insurance On-site parking Employee assistance programme Virtual GP Cycle to work scheme Subsidised canteen Employee discounts and cash back Gym membership discounts Family friendly policies Employee recognition programme Loyal service awards


Kedrion Biopharma is a biopharmaceutical company headquartered in Italy dedicated to collecting and fractionating blood plasma to produce and distribute plasma-derived therapies worldwide. These treatments help manage and prevent rare, ultra-rare, and debilitating conditions, including Coagulation and Neurological Disorders, Immunodeficiencies, and Rh sensitization.
The Kedrion group has numerous legacies within its brand; your employer will be Bio Products Laboratory Ltd, doing business as Kedrion Biopharma UK. Our plant is based in Elstree and counts nearly 1000 colleagues across various departments.


Since its foundation, Kedrion has experienced consistent growth, backed by strong performance indicators. Today, the company employs 5,200 people globally who work collaboratively on our portfolio of 38 life-enhancing plasma-derived products distributed in over 100 countries.


Please apply today for immediate consideration!