Microbiology Validation Analyst

Kedrion Biopharma is looking to recruit a Microbiology Validation Analyst to join the Quality Department located on site in Elstree. The position entails expertly gathering and assessing samples in accordance with Microbiology's Standard Operating Procedures, protocols, our Policies, and GMP principles.

Duties & Responsibilities will include:

• To perform a wide variety of microbiological tests and validation studies in accordance with Standard Operating Procedures, protocols, BPL policies and GMP.
• To perform reviews of data, including trending and statistical analysis.
• To perform annual reviews of equipment, spreadsheets, data and documents.
• To generate Quality checklist reports and write validation reports.
• To read, collate, report and archive results using defined documentation and computer systems.
• To ensure equipment used is clean, calibrated and maintained.
• Responsible for preparing reagents, standards and control samples and contribute to general laboratory housekeeping duties.
• Ensure good stock control.
• To promptly report any deviations, out-of-specification / limits results.
• To assist where required with investigations.
• To operate a variety of instrumentation and computer software packages intended for data analysis, collation and other related applications (e.g. LIMS).
• To make recommendations for documentation revision.
• Undertaking administrative activities.
• To observe laboratory health and safety instructions regarding the use of personal protective clothing and equipment and contribute to the development and improvement of safer working practices.
• To assist in generating risk assessments.
• To organise own assigned working activities.
• To be responsible for reporting issues or delays to laboratory management.
• To assist with the calibration or validation of laboratory equipment and automated systems.
• To identify continuous improvement initiatives.
• To attend meetings as required.
• To participate in the receipt of audits from internal (BPL) and external sources.
• To adhere to record and data integrity requirements, as per BPL policies.
• To perform any other aspects of validation testing and support the microbiology validation objectives of the department as required.

Health & Safety: Follow the BPL Health & Safety policy and guidelines. Bring any risks or issues to the attention of your manager or the SHE department. Focus on improving Health and Safety at all times.

Policies: Work in accordance with relevant BPL Policies.

Project Management: Assist in projects as and when required (including but not limited to; testing of samples, preparation of components, reporting of results, etc.).

Skills & experience to help you within the role:

• Degree in a relevant scientific discipline.
• Experience of working in a laboratory environment (ideally microbiology).
• Understanding of GMP/GLP.
• Good knowledge of the pharmaceutical industry, both within a laboratory and across pharmaceutical processes.
• Knowledge of laboratory SOPs and ability to revise and write new procedures.
• Understanding of laboratory operations and practical work.
• Knowledge of stock control and budgeting in own area.
• Experience in using analytical equipment and pipettes.
• Experience writing reports.
• Self-driven and independently motivated.
• 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.
• Attention to detail - Able to ensure high levels of quality are achieved.
• Communication skills - Able to communicate clearly and persuasively with your team, managers, peers, and clients.

In return we offer:

• 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.

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. 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.

Please apply today for immediate consideration.