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

• Undertakes such other reasonable duties as may be required from time to time to support the

department and business activities.

• Acknowledge responsibility to ensure an effective Quality Management System in order to achieve

Quality Objectives.

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.