QC Technical Transfer Analyst

Major Duties and Responsibilities

• Ensure that lab cleanliness and safety standards are maintained

• Perform visual inspections of finished products

• Perform analytical testing of finished using validated methods at a high RFT

• Performs analytical testing and Micro/PET to USP, EP, BP monographs at a high RFT

• Identify and troubleshoot equipment problems

• Receive and inspect raw materials & Packaging components

• Review data from internal testing & contract laboratories to ensure accuracy and regulatory compliance.

• Participate in out-of-specification and failure investigations and recommend corrective actions.

• Perform Routine calibration of instrumentation to in house SOPs & WRKs

• Revise standard quality control operating procedures & WRKs

• Identify and reports quality events to line manager

• Ability to document all Chemistry, Micro or packaging analysis independently

• (Expanding Proficiency)

• Supports delivery of Key QC systems such as stability study management, RM risk assessments,

reference standards management, environmental monitoring reports and trending

• Ability to write technical reports e.g., end of stability reports, reduced testing risk assessment,

validation protocols and reports

• Demonstrates some competencies of QC instrument maintenance or Qualification

• Write or revise standard quality control operating procedures & WRKs

• Identify quality events and potential root cause determination

• (Bridging Proficiency)

• Collate and Supply quality control data necessary for regulatory submissions.

• Prepare or review required method transfer documentation including technical transfer protocols or

reports.

• investigates quality events and potential root cause determination

• Ability to Investigate questionable test results (OOS, OOT, Aberrant)

• QC Analysts at expanding or bridging proficiency must also be able to demonstrate the following

abilities:

• Business awareness

• Customer service

• 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-2-4 years experience

• Minimum Expected Education-Level 6 – Bachelor’s Degree

• Additional Information-University Degree; Typically a minimum of 2 years

work experience required, A minimum of two A’ levels or T Levels in a suitable, scientific discipline + more than 3 years analytical, experience in a GMP laboratory.