Quality Control (QC) is responsible for the routine testing of In-process, Drug Substance, Drug Product, and Stability samples for internally and externally manufactured Biopharm products. It is also responsible for ensuring that analytical tests are successfully transferred to the BioCTL, and method validation is performed where appropriate.
To achieve this, the BioCTL team conduct biochemical analysis of products and provide specialist and technical scientific knowledge and expertise to evaluate all aspects of the laboratory functions.
Key Responsibilities (10 bullet points maximum)
Describe the key deliverables to be achieved by the post holder and the ongoing responsibilities of the role
To independently perform analysis of samples submitted from both internal and external manufacturing sites for which the job holder has been trained.
- To test samples utilising a range of chemical, biochemical and biological tests, in accordance with regulatory requirements and agreed schedules. To apply a knowledge of Physico-chemistry testing to the provision of product testing and stability data. To be familiar with chemical and biochemical methods, test specifications and sampling regimes, and the impact they may have on the product.
- To work with the line manager or designated analyst to interpret tests results as required. Work in a safe manner and in compliance with Safety Codes of Practice and policies.
- To maintain detailed laboratory records in accordance with current Good Manufacturing Practice (cGMP) through the use of controlled pro forma or laboratory notebooks.
To ensure that all records and test results are accurately prepared and checked, peer reviewed prior to submission for approval for authorisation and according to company, customer and regulatory requirements.
- Record deviations from the normal practice and out of specification results appropriately and report them to the line manager; assist with investigations product and test anomalies.
- To deliver and assess formal training programmes for staff and trainees as required.
· Responsible for the condition and maintenance of the laboratory equipment, ensuring records are maintained of any calibration, maintenance. Ensure that the department is kept in a safe, clean and orderly fashion and maintained in an inspection ready state.
- To facilitate the ordering of laboratory consumables to ensure efficient running of the laboratory.
- To be responsible for the safe storage and/or disposal of test samples, reference materials and reagents following set procedures. To record incoming samples according to the appropriate SOPs. To ensure all samples and materials are handled safely following departmental procedures.
- Write, review and update SOPs and associated pro-forma used within the laboratory, prepare draft method of analysis and SOPs when new techniques are introduced in the area.
· To participate in the validation of test methods and equipment used in analysis to meet regulatory
- To use Root Cause Analysis and other OE tools.
Knowledge/ Education / Previous Experience Required*
A. Educational Background
List any academic or practical education that must be obtained to be qualified to perform this role.
1. Minimum Level of Education*
B.S. in Biochemistry, Microbiology, Biology, or Chemistry
Area of Specialisation*
Biochemistry, Microbiology, Biology, or Chemistry
Why is this Level of Education Required?
- Biochemistry degree or relevant equivalent and three years analytical experience
- To understand the principles of immunological assays.
- Has knowledge and understanding of biochemical techniques and analytical disciplines aligned to chemistry in the context of biopharmaceutical product release.
· Computer literate and competent in the use of corporate IT systems and software analysis packages
2. Preferred Level of Education
Masters in Biochemistry, Microbiology, Biology, or Chemistry
Area of Specialisation
Biochemistry, Microbiology, Biology, or Chemistry
Why is this Level of Education Preferred?
Ability to work with peers in across GSK. Ability to troubleshoot and review assays.
B. Job-Related Experience
Describe what experience this position will require the job holder to have obtained in past roles within or outside of GSK that would demonstrate a level of proficiency in the stated role.
Minimum Level of Job-Related Experience required
- Has knowledge and understanding of the principles of data review and checking within a GMP environment.
- Has an understanding of working to GMP and GLP compliance.
- Willing to be involved in working with a team as well as independently.
- Has a keen eye for detail.
- Is literate, numerate and computer literate.
- Has good planning and organising skills with ability for problem solving.
- Is able to communicate effectively with colleagues and managers within laboratory.
- Reliable and interested to learn and apply new techniques.
- Why is this Level of Experience Required?
Highly regulated and complex environment, Ability to effectively manage workload.
C. Other Job-Related Skills/Background
List any licenses, certificates, registrations, or any relevant job skill or abilities not covered in Educational Background or Job-Related Experience sections above that are required for the job.
· Plans and organises own and other team members workload over 1 week period
· Establish and implement short term priorities.
· Day to day planning of own work and completes tasks to deadlines as agreed with Laboratory Supervisor.
· Short horizon planning for OOS investigations.
· Ensure that EHS policies and procedures are adhered to and reviewed as required.