Senior QC Analytical Analyst
"Join a rapidly expanding GMP QC Laboratory that will offer you the opportunity for growth and development"
Job Title: QC Senior Technologist (Analytical Chemist)
Reference No: 229271
Job Type: Permanent
Salary: c£29K plus excellent benefits
Analytical Quality Control Laboratory
The Analytical Quality Control Laboratory is part of a group which develops and manufactures biopharmaceutical products according to cGMP requirements. The laboratory is responsible for provision of analytical chemistry services to support quality control testing of products, raw materials and water systems.
MAIN DUTIES AND RESPONSIBILITIES
* To schedule work for QC Analytical staff members to ensure that manufacturing deadlines are met.
* To ensure analysis and recording of QC and stability testing has been performed in compliance with the statutory requirements of cGMP.
* Responsibility for testing raw materials, in process and finished product samples to ensure that they meet the specifications
* Organise and liaise with external testing laboratories to arrange correct and on time testing to meet production deadlines.
* Responsible for the verification of analytical raw data and release of results from the QC Analytical department.
* Responsible for writing quality records such as non-conformances, CAPAs and change controls.
Qualification - Essential
Degree in Chemistry/Biochemistry or other suitable degree. Suitable experience may be considered as suitable.
Knowledge and experience - Essential
Working Knowledge / Experience of cGMP.
Working Knowledge / Experience of the EP and USP.
Working Knowledge / Experience of ICH requirements.
Previously worked in a similar laboratory as a bench analyst following written instructions and comparing analytical results with set specifications.
Experience of the out of specification process and carrying out laboratory investigations.
Experience using standard analytical laboratory equipment such as pH meters, balances, pipettes.
Ability to supervise junior staff and schedule workloads.
Knowledge and experience - Desirable
Knowledge / Experience of Enzyme analysis.
Knowledge / Experience of Waters HPLC systems and associated software or equivalent.
Knowledge / Experience of Gel Electrophoresis.
Knowledge / Experience using UV-Vis and FT-IR.
Knowledge / Experience using KF Moisture determination.
Knowledge / Experience analysing purified water and water for injection.
Knowledge / Experience analysing pharmaceutical raw materials.
Experienced in supervising junior staff and scheduling workloads in a similar situation.
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