Senior QC Microbiologist
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Job Summary
Work Schedule
12 hr shift/daysEnvironmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards Cleanroom: no hair products jewelry makeup nail polish perfume exposed piercings facial hair etc... allowed Laboratory Setting Office Some degree of PPE (Personal Protective Equipment) required (safety glasses gowning gloves lab coat ear plugs etc.)Job Description
Senior QC Analyst Microbiology
- Job Profile Title: Engineer Scientist II QC
- Career Band: 5
- Career Track: Professional
- Location: Swindon
- Shift Pattern: 4 On / 4 Off
- Reports To: Section Head Quality Control
- Group Division: PSG
- Number of Direct Reports: 0
About Thermo Fisher Scientific
At Thermo Fisher Scientific each of our more than 70000 colleagues brings a unique story expertise and perspective. Together we share a singular mission to enable our customers to make the world healthier cleaner and safer. As part of our organisation you will perform challenging and meaningful work supported by a culture that values quality performance innovation and continuous improvement.
Position Summary
The Lead QC Scientific Officer is an experienced QC Microbiologist who provides hands-on scientific expertise and day-to-day operational supervision within the Quality Control Microbiology function.
The role supports the QC Section Head through planning organising and coordinating team workload ensuring activities are executed in compliance with cGMP data integrity and site quality systems. The position operates as a subject matter expert within the team and contributes to audit readiness regulatory compliance and continuous improvement initiatives. Regular interaction with internal and external stakeholders is required and the role will deputise for the Section Head when necessary.
Key Responsibilities:
- To transfer methodology into Patheon to perform routine laboratory procedures and to perform project work within the department.
- To carry out projects within the Department and at international level as required.
- To prepare technical documentation within the Department as required.
- To assist in the development and validation of laboratory procedures within the team as required.
- To train others as required.
- To review analytical and laboratory data within the Department for accuracy completeness and compliance with documented procedures.
- To communicate effectively with others on site and internationally and to participate with them in problem solving activities as required.
- To assist in the development and validation of laboratory procedures within the team and with other organisations internationally as required.
- This includes but is not limited to purchase & qualification of equipment.
- Ensure cGMP is applied in their area of work and comply with cGMP in all areas of the business.
- To carry out any other tasks which may be required from time to time
Leadership Responsibilities:
- Ensure the weekly plan is understood by the team and activities are organised to achieve agreed targets and measures of performance:
- Ensure equipment status and readiness are effectively monitored and maintained - this will include that any faults or issues are reported.
- Assure timely review of the data for the delivery of the batch.
- Managing change control or CAPA actions
- OOS investigations and deviation investigation handling
- Ensure that all equipment are maintained in accordance with GMP
- Timely escalation of all issues that cannot be resolved.
- Tracking of progress and downtime reporting escalating issues as appropriate.
- Accurate and timely completion of the analytical activities within the team
- Effective team leadership in line with GMP requirements and 4i values policies and procedures.
- Ensure own and teams work complies with GMP & Data Integrity and is undertaken in accordance with applicable quality documents e.g. SOPs Analytical Methods Specifications etc.
- Plan training ensure execution and maintain training matrix.
- Provide coaching and guidance to the team
- Client facing
- Ensure Continuous improvements - Identify and support PPI initiatives to eliminate or/and reduce waste and non-value adding activities within the Lab
- Deputise for the Section Head in their absence
- Support and encourage a Quality Culture throughout the QC Microbiology Lab.
EH&S:
- Understand emergency procedures and comply with safe systems of work.
- Ensure compliance with environment health and safety rules signage and instructions at all times.
- Ensure prompt reporting and investigation of all accidents near misses and breaches of rules.
Qualifications/Experience:
- Degree in Microbiology or strongly related scientific discipline.
- Experience of instrumental and traditional analytical techniques.
- Ability to work to critical timelines with the ability to commit to overseas travel as part of the project team.
- Effective communication skills at all internal and external levels.
- Excellent attention to detail.
- Excellent organisational skills.
- Ability to coach others.
At Thermo Fisher Scientific each one of our 70000 extraordinary minds has a unique story to tell. Join us and contribute to our singular missionenabling our customers to make the world healthier cleaner and safer.
Required Experience:
Senior IC
Key Skills
- Laboratory Experience
- Virology
- FDA Regulations
- Infusion Experience
- Laboratory Procedures
- PCR
- Biotechnology
- Microbiology
- Quality Control
- GLP
- cGMP
- QA/QC
About Company
Electron microscopes reveal hidden wonders that are smaller than the human eye can see. They fire electrons and create images, magnifying micrometer and nanometer structures by up to ten million times, providing a spectacular level of detail, even allowing researchers to view single a ... View more
