Senior Associate Scientist QC Environmental Monitoring

Senior Associate Scientist QC Environmental Monitoring

Your role:

The Associate Scientist Senior - QC EM performs a wide variety of routine tasks to support Environmental Monitoring (EM) for the GMP manufacturing facility. You will ensure tasks are allocated to appropriate personnel and that these are completed compliantly and in a timely manner. You will ensure that laboratories are maintained to the required health, safety and housekeeping standards; equipment is monitored and maintained and that consumable and reagents are readily available for use. You will provide guidance and training to less experienced employees but will not have direct line management responsibility.

In addition, you will lead investigation of environmental monitoring related events (as appropriate), ensuring identification of root cause and implementation of any related CAPA plans. The ability to develop and maintain effective working relationships with manufacturing, support services and quality assurance personnel will be critical for success in this role.

Specific responsibilities:

• Works within the QC EM laboratory, and the GMP manufacturing facility, following Standard Operating Procedures to perform and accurately record environmental monitoring and isolate identification to meet GMP requirements
• Demonstrates good technical knowledge and support for environmental monitoring and problem solves within areas of expertise
• Leads team by example as an active participant in the laboratory, providing co-ordination, process supervision for assigned tasks, hands on support and mentoring, within level of technical expertise, to more junior personnel
• Organises and plans laboratory workload to ensure resources are used efficiently and effectively to complete tasks and activities
• Co-ordinates and/or carries out housekeeping and equipment checks and performs inspections to ensure that laboratory compliance is maintained
• Co-ordinates environmental monitoring activities with the manufacturing and facilities teams
• Responsible for raising technical concerns/issues related to laboratory or cleanroom activities to line manager as appropriate
• Promptly performs routine peer review of raw data records, and review of completed lab documentation, as required
• Maintains stock control in the laboratory and orders consumables and reagents through i-procurement
• Raises and progresses deviations and investigations in a timely manner.
• Ensure calibration and validation of scientific equipment and instruments
• Performs environmental and personnel monitoring activities (or ensures that they are performed) updating electronic records both promptly and accurately
• Proactively identifies and implements improvements to laboratory processes and procedures to improve efficiencies and reduce waste.
• Ensures, actively promotes and maintains a clean, tidy and safe work environment. Ensures Health and Safety expectations of the workplace are met.
• Trains and mentors newer members of staff
• Demonstrates good communication and interpersonal skills with employees and management

The Associated Scientist Senior QC EM is a member of the QC Environmental Monitoring team and reports to the Manager, Quality Improvement.

Who you are:

• You have an HND or higher qualification in Microbiology or a related subject
• You will have a minimum of 4 years' experience in a scientific laboratory role, ideally within a GMP environmental monitoring laboratory
• Previous experience of performing plate reads, gram stains and API identifications would be advantageous
• You are strongly focused on quality and safety
• You have strong planning and organisational skills
• You have good communication and interpersonal skills
• You are self-motivated with strong initiative and drive

You have a good standard of written and spoken English and are computer literate, ideally with prior knowledge of working with LIMS.