דרושים Laboratory Tech - S1 ב-Boston Scientific ב-United Kingdom, Waverley

United Kingdom-Farnham

Broad Function

The role provides analytical testing support for all pharmaceutical products manufactured at the Farnham site. Following BSC Quality Standards or Pharmacopoeia methods testing will cover raw materials, excipients, components, in-process samples and finished products. Testing will include a high proportion of visual and physical measurements associated with the testing of components. Performs qualitative tests or quantitative assays on samples using techniques that vary from use of standard analytical equipment to highly modern and automated instrumentation. Responsibilities will also include documenting all work in a compliant manner, participating in OOS investigations, reviewing of analytical results to ensure accuracy and compliance to test methods, preparation of all laboratory documentation.

Principal Responsibilities

1. Ensure that departmental objectives are implemented in line with the overall Quality/Corporate goals.
2. Comply with all safety and GMP requirements within the Laboratory.
3. Plan daily schedule for self and others to meet testing requirements.
4. Train QC Analysts in various analytical and laboratory procedures.
5. Preparation and timely submission of test samples from raw materials, in-process and final product samples to both internal laboratories and to external test houses.
6. Operation of laboratory equipment including daily up-keep and maintenance and assist in trouble-shooting when required.
7. Working to Standard Operating Procedures/WIs, complete the sampling, inspection and analysis of Raw Materials or Components, In-Process and Final Product samples to defined Chemical, Physical and Pharmacopoeia test procedures to support Manufacturing and Development activities.
8. Document all testing activities to current BSC and regulatory standards.
9. Review analytical results to ensure accuracy and compliance to both test methods and registered specifications.
10. Preparation and revision of laboratory protocols, reports, procedures and WIs.
11. Assist in the Innovation and development analytical processes to meet internal and international method validation requirements to support any QC, R&D or Manufacturing activity.
12. Lead OOS/OOT investigations, utilising technical knowledge to identify assignable cause and corrective actions.
13. Lead and participate in investigations for Quality Events, Complaints and review/generation of Change controls.
14. Manage information to support monitoring and evaluation of cGMP compliance including Key Performance Indicators (KPI). Prepare metrics to visualise KPIs.
15. Participate in and facilitate improvement programs within the Laboratory.
16. Participate in multi-functional teams to support project assignments.
17. Ensure that all interactions and engagements are carried out with the highest ethical and professional standards and that all work is accomplished with quality and in accordance with BSC values.
18. Ensuring that all interactions and engagements are carried out with the highest ethical and professional standards and that all work is accomplished with quality and in accordance with BSC values - quality and responsiveness are key.
19. Carry out other reasonable tasks as required by the Line Manager.

The above duties and responsibilities are not an exhaustive list and you may be required to undertake any other reasonable duties compatible with your experience and competencies. This description may be varied from time to time to reflect changing business requirements.

Principal Relationships

• Accountable to – QC Team Lead
• Internal – All levels of employees and management at Farnham site.
• External – Regular contact with non-Farnham Boston Scientific staff and with external visitors and suppliers.

Education and Experience required

• Educated in Science or related discipline.
• Relevant experience in the Pharmaceutical Industry.
• 1-2 years’ experience in an analytical Laboratory is preferable.
• Knowledge of quality systems and experience of working in a regulated environment preferred.
• Good knowledge of GLP/GMP.
• Knowledge and experience in the following analytical techniques: Gas Chromatography and HPLC/UPLC.
• Understanding and application of COSHH regulations in a chemical industry.

Skills and Attributes required

• Demonstrated advanced computer skills – Microsoft Office preferred.
• Good written and verbal skills.
• Ability to perform precise and constant analysis in support of analytical testing.
• Ability to complete assignments in a timely manner and communicate progress at intervals.
• Ability to analytically evaluate results.
• Self-starter capable of delivering consistent results to a high level.
• Team player and able to interact with colleagues in a constructive and positive manner

United Kingdom-Farnham

Broad Function

The role provides microbiological and analytical testing support for pharmaceutical products manufactured at the Farnham site. Following BSCI Quality Standards or Pharmacopoeia methods, testing will cover water sampling & testing, environmental monitoring of cleanrooms & testing of in-process samples and finished products. The job holder will be required to document work in a compliant manner, with good attention to detail and good documentation practice. Daily entry into cleanroom environments is expected.

Principal Responsibilities

1. To ensure that departmental objectives are executed in line with the overall Quality/Corporate goals.
2. To comply with all safety and GMP requirements within the Laboratory and Cleanrooms.
3. To execute analytical testing for microbiology requirements to support any QC, R&D or Manufacturing activity. Routine activities include bioburden testing, endotoxin testing, Analytical testing of water samples (TOC and Conductivity), environmental monitoring (Active air, settle plate, contact plate & non-viable particles)
4. To ensure preparation and timely submission of test samples to external test houses.
5. Where required working to Standard Operating Procedures/WIs, complete the environmental sampling of cleanroom environments.
6. Ensure documentation of all testing activities to current BSCI and regulatory standards.
7. To liaise with all external contract testing laboratories.
8. Input of data to support Key Performance Indicators (KPI) and trending.
9. Participate in multi-functional teams to support project assignments.
10. Interact with the electronic QMS, initiating quality event investigations, updating documents
11. Author reports to support product release and analysing environmental trends
12. Own & manage a QC Microbiology process to ensure compliance to calibration and maintenance requirements
13. Ensure that all interactions and engagements are carried out with the highest ethical and professional standards and that all work is accomplished with quality and in accordance with BTG values.
14. Complete additional tasks considered necessary to meet business and customer requirements as indicated by the Line Manager.

The above duties and responsibilities are not an exhaustive list and you may be required to undertake any other reasonable duties compatible with your experience and competencies. This description may be varied from time to time to reflect changing business requirements.

Principal Relationships

1. 1. Accountable to – QC Microbiologist Lead, Microbiology Team Laboratory
   2. Internal – Manufacturing, warehouse, engineering and QA
   3. External – Test Houses

Education and Experience required

1. Educated to BSC (minimum) in Microbiology, applied biology or a related discipline.
2. Experience with environmental monitoring of cleanrooms preferred
3. Experience in bioburden and endotoxin testing preferred
4. Experience of working to GMP and to Good Documentation practice

Skills and Attributes required

1. To demonstrate computer skills – Microsoft Office preferred.
2. Good written and verbal skills, to enable communication of technical information in a concise manner.
3. To complete assignments in a timely manner and communicate progress at intervals.
4. To analytically evaluate results.
5. Be a self-starter capable of working on their own and under supervision
6. Must be a team player and be able to interact with colleagues in a constructive and positive manner.
7. Ability to manage changing priorities