QC Specialist

My client is seeking to recruit a QC Specialist to join their Separations Laboratory, the function of which is to support drug product and drug substance release testing. The successful candidate will be involved in assisting in laboratory operations, performing testing of samples and performing laboratory duties in accordance with cGMP regulations.

The role:

• Performing release testing for biological products.
• Assisting in updating and issuing documentation, including SOPs, as required.
• Performing routine data analysis, assist in the investigation of OOS results, perform trending analysis and writing investigation reports.
• Accurately documenting laboratory work.
• Execute and assist in technical transfer and co-validation activities.
• Assisting with qualification of laboratory instruments.
• Data review based on demonstrated proficiency on assays.

Qualifications and Experience:

• Previous experience in a regulated biopharmaceutical laboratory is preferred. HPLC/UPLC and Empower experience is preferred but not essential.
• The ideal candidate should hold a minimum of a BSc. in Biochemistry or related discipline.
• The successful candidate must demonstrate an ability to work independently and recognize anomalous trends or results.
• Must demonstrate problem solving ability, as well as the ability to prioritize objectives from multiple projects and adhere to scheduled timelines.
• Excellent communication and the ability to work in a team based collaborative environment are required.

The Next Step for you:

Should this position be of interest to you please forward your CV to Barry O'Mahony from Next Generation Recruitment or alternatively call on the main line on 016629120

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