QC Chemist II
ThermoFisher Scientific
**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, No contact lens allowed; prescriptive glasses will be provided, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Will work with hazardous/toxic materials
**Job Description**
Reporting to the QC Manager Chemistry, the role is responsible for writing laboratory procedures, transfer/verification/validation of methodology, and project work within the department to support manufacture and release of pharmaceutical raw materials, intermediates and products. The role gives to building and maintaining QC lab cGMP system, delivers analytical solution to clients through expertise in specific method qualification and validation strategies while ensuring timely delivery for projects. The role will be driving activities such as testing for incoming materials, in-process products and DS testing, etc.
**Responsibilities:**
+ To support new equipment qualification, lab computerized system and new chemistry lab set up
+ To perform transfer/verification/validation of laboratory procedures within the team where required
+ To prepare technical documentation including but not limited to protocols, analytical write-ups, standard operating procedures, specifications, investigations and reports.
+ Lead lab system deployment and routine maintenance as site SME, e.g., CDS, LIMS.
+ To perform analysis of incoming goods, intermediates and/or finished products under cGMP conditions for QC release or as part of stability studies.
+ To review analytical and laboratory data within the department for accuracy, completeness and compliance with detailed procedures.
+ To perform planned preventative maintenance and performance calibrations on equipment.
+ Management of QC chemical, reference standard and consumable stock levels
+ To maintain own training records and support and train other team members as required.
+ To communicate effectively on site and internationally, and to participate with them in problem solving activities.
+ Participate/chip in Practical Process Improvement initiatives (PPI) or continuous improvement in the lab
+ Support and encourage a “Quality Culture” and company 4i values throughout QC
+ Ensure cGMP is applied in their area of work and align with cGMP in all areas of the business.
+ To work with HSE, cGMP and 5S in mind at all times.
+ Undertake ad-hoc activities that may be required by the business
+ To support shift work (if necessary) in future
Keys to Success:
**This is a fixed term (1 year) role.**
**Education**
+ Degree in Chemistry or strongly related scientific field
**Experience**
**·At least 5 years relevant industrial experience**
+ Experience in equipment such as Capillary Electrophoresis (CE), Microplate Reader preferred
+ Ability to apply GMP regulations and other international guidelines to all aspects of the position.
+ Ability to work independently and adhere to critical timelines
+ Effective communication skills at all internal and external levels
+ Excellent attention to detail
+ Excellent organisational skills
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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