QC Analyst
Job Title : QC Analyst
Department : Quality Control (QC)
Location : Welwyn Garden city, Hertfordshire
Key Duties and Responsibility
Sciom Limited was founded in 2023 with a clear purpose in mind - to provide unparalleled quality control and microbiology services to the pharmaceutical and biosciences industry.
Release and stability testing of QC samples, raw materials and finished products, are performed using HPLC, GC, UV, FTIR, Dissolution, and Karl Fischer analysis with appropriate documentation and strict adherence to Good Documentation Practices.
To test bulk all physical parameters for all tablets, capsules, finished product samples against the specification.
To develop and validate analytical methods for the testing of manufactured products to agreed specifications that remains in compliance with current relevant pharmacopeial standards and requirements.
To perform trend analysis of QC analytical results and investigate any OOT/OOS analytical according to the relevant SOPs.
Participate in documentation, laboratory systems and processes to include updating existing ones as required.
Preparation of Mobile phases, reagents for analysis.
To write reports, SOPs and other documentation when required.
Perform the Calibration, maintenance and Validation for all laboratory analytical instruments
Perform microbiological testing with respect to full identification of organisms, media fills, bioburden, sterility and endotoxin tests of sample analysis.
Any other duties as and when required.
Essential Experience, Skills and Abilities
Relevant degree in a scientific discipline Previous experience working in a laboratory environment Experience of HPLC analysis and troubleshooting.
An understanding of GMP/ Pharmacopeia Experience of working in the Pharmaceutical Industry Worked by Standard Operating Procedures Proficient in the use of Microsoft Office including Word and Excel.
Good knowledge of GMP, ICH guidelines, BP/EP/USP methods with an understanding of QA processes and methodologies.
Able to work methodically and to tight deadlines.
Strong hands-on experience of undertaking testing, analysis and development using instrumentation analysis such as HPLC GC Dissolution UV FTIR in a cGMP environment.