Kedrion Biopharma has a new and exciting opportunity for a Stability Analyst to join the Quality Department and contribute to the Quality Laboratory function at BPL, through competently taking and despatching stability samples and processing test results in accordance with departmental Standard Operating Procedures, BPL Policies, and to the principles of GMP located on-site in Elstree, Hertfordshire.
This role will suit a recent Graduate who has work experience in data evaluation and reporting on samples or someone who has worked within a lab environment within a statistical focused or data handling role who and is now wanting a part time job. You must be confident working with laboratory software such as LIMS and computer literate.
This job is part time only, three days a week.
Our site is not easily accessible by public transport so please take this into consideration when applying as this role is fully on-site.
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 –
* 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.
Skills & Education required to help you within the role –
* Degree level qualification in science discipline or equivalent such as Mathematics is desirable
* Experience in using analytical equipment and pipettes
* Experience in writing reports.
* Understanding and knowledge of laboratory operations and practical work.
* Experience of working in a laboratory environment is essential
* Understanding of GMP/GLP is desirable
* Good knowledge of the pharmaceutical industry, both within a laboratory and across pharmaceutical processes is desirable
* Knowledge of laboratory SOPs and ability to revise and write new procedures is desirable
* 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
We're looking for highly motivated and experienced people to drive the business forward. If you are passionate about joining a Pharmaceutical Manufacturing company and learning about life changing products then we want to hear from you.
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.