QC Lab Manager (Assistant) – GMP/GLP, Method Dev

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

Job summary

Pharma - Contract Manufacturer in Smithfield NSW is seeking an experienced Assistant Lab Manager. The role focuses on quality control testing of raw materials, in-process and finished products using HPLC and other techniques, with responsibility for GMP/GLP compliance and regulatory audits.

The candidate will train staff, develop methods, manage lab operations, and contribute to ongoing QA activities in a growing pharmaceutical environment.

Qualifications

• Minimum 7 years hands-on experience with HPLC and other analytical techniques.
• Experience in quality control laboratory operations and documentation.
• Familiarity with GMP and GLP environments would be advantageous.

Responsibilities

• 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

Skills

Quality control

GMP/GLP knowledge

Regulatory audits

Tools

HPLC

GC

FTIR

UV-Vis

ICP-OES

Job description

Pharma - Contract Manufacturer in Smithfield NSW is seeking an experienced Assistant Lab Manager. The role focuses on quality control testing of raw materials, in-process and finished products using HPLC and other techniques, with responsibility for GMP/GLP compliance and regulatory audits.

The candidate will train staff, develop methods, manage lab operations, and contribute to ongoing QA activities in a growing pharmaceutical environment.