Microbiology Validation Analyst

at  Bpl

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.
Come be a part of our team in upholding excellent microbiology standards at Kedrion and apply today!
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.

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 polices.
• To identify continuous improvement initiatives.
• To perform any other aspects of validation testing and support the microbiology validation objectives of the department as required.

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 knowledge of laboratory operations and practical work.
• Knowledge of stock control and budgeting in own area
• Experience is 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.
  We’re looking for highly motivated and experienced people to drive the business forward. If you are passionate about microbiology and working with a reputable pharmaceutical manufacturing company, then we want to hear from you.