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Assistant QC Analyst

 

Major Duties and Responsibilities
 
• Ensures that lab cleanliness and safety standards are maintained (Aseptic technique trained in Micro)
• Ability to perform physicals testing of finished products, Raw materials & Components
• Performs analytical testing of Finished or Stability batches using validated HPLC methods
• Performs RM analytical testing or Micro/PET to USP, EP, BP monographs
• Identify and report equipment problems for Tech. support resolution
• Receive and inspect raw materials & Packaging components
• Revise standard quality control operating procedures & WRKs
• Identify and reports quality events & OOS/OOTs to line manager
• Ability to document all Chemistry, Micro or packaging analysis following good data documentation
practice with minimal supervision
• (Expanding Proficiency)
• Trained & competent in multiple analytical instrumentation techniques, including HPLC, GC,
Dissolution, conductivity/TOC, FTIR
• Ability to perform analysis consistently at a high RFT > 90%
• Demonstrates some competencies of QC instrument troubleshooting
• (Bridging Proficiency)
• Demonstrates independent data documentation, processing & trend awareness
• Ability to review data from physicals tests or basic HPLC or GC assays
• Performs report writing with minimal supervision e.g. Micro validation, end of stability reports etc.
• QC Assistant Analysts at expanding or bridging proficiency must also be able to demonstrate the
following abilities:
• Business awareness
• Effective Communication
• Problem solving
• Team Work
Competencies
 
• To communicate instantly any problems/queries concluded by the Laboratory to the Quality Control
Supervisor or QC and Stability Manager.
• Respond promptly to requests and concerns.
• Complete business objectives.
• Ensure the cleanliness and tidiness of your individual workstation and to ensure a standard of good
housekeeping in all areas of the Company.
• Provide flexibility if required when requested to work out side of normal working hours.
• Ensure behaviours follow company policies and departmental expectations
Knowledge and Experience
 
•Typical Years of Experience-0-2 years experience
•Minimum Expected Education-Level 6 – Bachelor’s Degree
•Additional Information- University Degree; Typically no years work
experience required, understanding of the basics
of Pharmaceutical GMP. A minimum of two A levels or T Level in a scientific discipline plus more than 1 years analytical experience in a GMP laboratory.
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