Environmental Monitoring Team Analyst
Oil & Gas
One of the world's leading private biotechnology companies, developing and manufacturing innovative biotechnology-based medicines for human healthcare products, with a focus on microbial-derived biologics .
PURPOSE OF JOB
The Analyst provides analytical support to Biologics manufacturing and its facilities as a member of the Environmental Monitoring Team. The job holder is responsible for following management direction and complying with the technical, operational, SHE and cGMP of their work to generate high quality, relevant, accurate and timely data to support production and ensure the manufacturing facilities are monitored in accordance with the required schedules. The jobholder will be expected to identify anomalies with data and contribute to the team objectives. The environmental team work a flexible early,days,late (EDL) shift pattern according to manufacturing requirements.
1. To ensure all sampling and laboratory work undertaken is performed in accordance with cGMP quality system. The consequences of getting this wrong can range from the loss of data to support the use of material in clinical trials, to the loss of marketed batch of material. This could lead to lengthy delays for client programs and potentially to loss of business and company reputation.
2. Identify concerns with processes, methods or data and where possible develop or contribute to the development of solutions with management support.
1. To ensure that all work undertaken complies with safety assessments contained with analytical methods and risk assessments.
1. To follow management advice and guidance and act as a team player.
2. To follow plans & objectives set for the team.
3. To have own work plan over period 1-7 days.
4. To generate data following applicable quality systems and local procedures to ensure accurate, well recorded, high quality data.
5. When required peer review of other data as part of the data checking processes.
6. To identify and raise concerns with management re: data anomalies or opportunity for continuous improvement.
7. Maintenance of key lab systems (eg: KanBan, 5S, etc.).
8. Good communication skills demonstrated within team.
9. Self-starting demonstrated willingness to research subject areas under development.
10. Flexibility to adapt to changing plans.
1. The jobholder must have the willingness to seek out knowledge and to develop their competence as they gain experience.
2. The jobholder must possess the ability to clearly communicate within their team.
3. The jobholder must demonstrate the ability to work well on a shift pattern, which includes competent handover of work to the next shift both in a written and verbal format to ensure excellent continuity of work.
4. The job holder must have the ability to generate data following local procedures and Quality process to assure the data.
5. The jobholder must be able to critique data/processes and identify concerns.
6. Microbiological analysis experience (minimum of six months)
1. Concern for standards
2. Results orientated
3. Ability to learn
4. Interpersonal awareness
ROLE SPECIFIC COMPETENCIES
• Ensuring all testing is performed in accordance with the specified requirements for the manufacturing assets;
o Environmental monitoring is performed as required.
o Water sampling and associated analysis is performed as required.
o Execution of monitoring for critical operations .
o Ensuring all analysed samples are processed and completed correctly, including read back of microbiological samples and submission for identification.
• Ensuring all trending is performed in accordance with the specified requirements for the manufacturing assets;
o Environmental monitoring data is trended as required.
o Water sampling and associated analysis is trended as required.
• Compile and report data from QC into other functions:-
o Utility Reports
• Manage the completion of LIs, NCRs,
o Ensure LIs are raised upon day of confirmation.
o Report any out-of-specification results to the appropriate personnel.
• Plan and execute new project qualifications;
o Liaise with the manufacturing asset representatives to determine specific requirements.
2. Excellent communication skills