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Headquartered in Elstree, Herts, BPL part of Kedrion, are an organisation where our products change people’s lives, and the purpose of our work is lived and breathed through its people.
Bio Products Laboratory manufactures pharmaceutical products derived from human blood plasma. These products are used to treat patients for conditions such as immunodeficiencies, coagulation disorders and critical care (blood volume deficiency).
We currently have an exciting opportunity for a Stability Analyst to join our Quality Team located in Elstree, Herts.
Please note our site is not easily accessible by public transport so please take this into consideration when applying.
The main purpose of your job role will be
To contribute to the Quality Laboratory function at BPL, through competently taking and testing samples in accordance with departmental Standard Operating Procedures, BPL Policies, and to the principles of GMP.
Key duties and responsibilities
- Set up stability trials, collect, pull and distribute Stability samples.
- Update Stability spreadsheets and records.
- Ship samples to outside testing laboratories (OTLs) and coordinate receipt of results back.
- Perform stability specific testing in accordance with Standard Operating Procedures, BPL policies and GMP.
- Provide practical and administrative assistance to the laboratories testing stability samples.
- Be responsible for preparing reagents, standards and control samples and contribute to general laboratory housekeeping duties.
- Promptly report deviations, out-of-specification / limits results. Assist where required with investigations.
- Read, collate, report and archive results using defined documentation and computer systems.
- Ensure equipment used is clean, calibrated and maintained. Perform system suitability checks where required
- Assist with the calibration or validation of laboratory equipment and automated systems.
- Ensure good stock control.
- Operate a variety of instrumentation and computer software packages intended for data analysis, collation and other related applications (e.g. LIMS).
- Make recommendations for documentation revision.
- Undertake administrative activities.
- Organise own assigned working activities. To be responsible for reporting issues or delays to next line management.
- Identify continuous improvement initiatives.
- Attend meetings as required.
- Participate in the receipt of audits from internal (BPL) and external sources, ensuring own work area is audit ready at all times.
- Adhere to record and data integrity requirements, as per BPL polices.
- Perform any other aspects of laboratory testing and support the objectives of the department as required.
Health & safety
- Follow the BPL Health & Safety policy and guidelines. Bring any risks or issue to the attention of your manager or the SHE department. Focus on improving Health and Safety at all times.
- 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. Assist in generating risk assessments.
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 & abilities required
- 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
- Works well under pressure and organise work to meet tight deadlines
- Works in a logical and systematic manner
- Learning on the job
- Practical laboratory skills
- Ability to understand and follow written instructions
- Able to work effectively with others
Knowledge & experience required
- Experience of working in a laboratory environment
- 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 and knowledge of laboratory operations and practical work
- Knowledge of stock control and budgeting in own area
- Experience in using analytical equipment and pipettes
- Experience in writing reports
Training & education required
- Degree in a relevant scientific discipline
In return we offer
- Competitive salary, and benefits to include a performance related bonus
- Pension
- Life Insurance
- 25 days holiday
- On-site parking and a subsidised restaurant
