Covance QC Scientist II in Harrogate, United Kingdom
Working as part of the QC Laboratory Operations Group, the QC Scientist routinely manages a number of assays pertaining to common techniques. Typically, the QC Scientist will work on single projects (for one or several related techniques), or be part of a larger cross-sectional project working in conjunction with a Lead Scientist (LS). Project requirements may include, but are not limited to; assay transfer, validation, sample analysis, batch/release testing, and stability studies. They will write protocols and reports, prepare and review analytical procedures, and be accountable for the approval and integrity of data and associated quality documentation. The QC Scientist has knowledge within a relevant field and is able to troubleshoot techniques in the area of their expertise. The management and approval of assay data by the QC Scientist forms a large area of responsibility for GMP projects. They may also be required to act as a Study Director or Principal Investigator for GLP projects, or Responsible Scientist for GCP projects. The QC Scientist is therefore required to adapt to changing regulatory requirements, depending on project types.
In this role, the QC Scientist will provide internal customers with a central scientific point of contact for techniques within their area of expertise, or for external Clients where the molecule is not overseen by a LS. The individual is accountable for effective communication either directly with the Client or via the LS to ensure that Client requirements and project deliverables are met. This involves discussion with the Client/LS to design proposals/protocols, the Project Management Office (PMO), and communication with QC Section Managers, as well as other scientific and analytical staff. The QC Scientist has scientific oversight of relevant techniques in order to ensure the successful initiation, planning, execution, monitoring and completion of projects.
The QC Scientist is required to have good working knowledge of the GMP/GLP/GCP and regulatory guidelines as they ensure that projects are carrried out to the required standards, and that work is conducted in compliance with applicable regulatory requirements.
The QC Scientist will be responsible for overseeing the work of other QC Scientists where appropriate. They will be expected to train, coach and mentor members of the team and across functions as required.
The individual will identify and communicate scientific and regulatory developments within their field of expertise, to include Lead Scientists, QC Scientists and Laboratory Analysts. The QC Scientist will represent Covance internally or externally by preparing and/or giving presentations, writing or supporting the preparation of scientific papers and/or posters, in order to communicate the work of Covance QC laboratory operations.
The QC Scientist will be required to perform lab work as required, and provide support with regards to general laboratory operations and processes, leading by example to members of the QC operations team.
Education / Qualifications
The post holder should ideally have a relevant degree and/or 5-6 years industry experience.
The ability to get things done by influencing others (both internal and external).
An up to date knowledge of regulatory guidelines.
Knowledge of capabilities and expertise of the Covance organisation and companies that may provide support services.
Commercial awareness, interpersonal and negotiating skills.
Learn and maintain knowledge of process excellence processes, tools and activities.
The post holder should typically have:
Computing skills, including word processing and use of spreadsheets (e.g. Microsoft Office packages and Microsoft Project).
An in-depth understanding of health and safety policies, Company policies and procedures, and a good understanding of GMP/GLP/GCP.
The post holder should be able to communicate effectively at all levels with other Covance employees, as well as external clients, suppliers, etc.
5-6 years industry experience in a relevant field.
Job Number 2018-17741
Job Category Scientific Advanced Degree
Position Type Full-Time
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