Senior QC Analyst

Pharma - Contract Manufacturer; Sydney; On-site; AUD 90,000 - 120,000; Full time

Job summary

Pharma - Contract Manufacturer, Smithfield NSW, is seeking a Senior QC Analyst with at least 7 years hands-on experience in HPLC and other analytical techniques to lead quality control activities.

You will perform raw material, in-process and finished product testing, develop and validate analytical methods, train staff, and support regulatory audits in a GMP/GLP environment.

Qualifications

• Minimum 7 years hands-on experience with HPLC and analytical techniques.
• Experience in analytical method development and validation.
• Proficient in GMP/GLP and regulatory audits.
• Experience with raw material, in-process and finished product testing.

Responsibilities

• Perform QC analysis of raw materials, in-process, and finished goods using analytical instruments.
• Create and update QC documents, specifications and test methods.
• Train staff and ensure regulatory compliance.
• Manage lab operations and participate in audits.
• Develop and validate analytical methods for materials and products.

Skills

HPLC expertise

Analytical techniques

Method development

Validation

GMP/GLP

Tools

HPLC

GC

FTIR

UV-Vis

ICP-OES

Job description

Pharma - Contract Manufacturer – Smithfield NSW

A growing pharmaceutical company has vacancyfor experienced Senior QC Analysts. This is a role for analysts with minimum 7 years hands-on experience with HPLC and other analytical techniques and substantial experience in analytical method development and validation.

Primary Objectives

Performprofessional quality control analyst assignments, including raw material testing, in-process testing and finished product testing using various analytical techniques and instruments (HPLC, GC, FTIR, UV-VIS, ICP-OES, etc)

Creating and updating QC Documents, including specifications and test methods, as required

Train staff and ensure compliance with regulatory requirements

Manage lab and handle regulatory audits

Develop and validate analytical methods for raw material and finished products

Job Description

Perform laboratory analysis of raw materials, finished goods and other samples using analytical instruments and analytical techniques

Prepare and label laboratory reagents, reference standards and solutions according to SOPs.

Record the results on the analytical report.

Order laboratory standards, chemicals and solvents.

Calibrate analytical instrument, as and when required.

Comply with GMP and GLP.

Follow safety procedures when working in laboratory.

Maintain the laboratory in an organized and neat manner

Assist in investigation of any OOS

Provide training to junior staff

Handle day to day operations of lab

Ensure compliance and Handle regulatory audits