MSD QC Bioanalytical Specialist 

Ireland, Dublin 

452633224

Job Description

What you will do:

Bring energy, knowledge, innovation and leadership to carry out the following:

• Supporting routine analytical testing with assays such as HPLC, CE, UV, Compendial, PCR and ELISA techniques on Release, In-process, Raw Materials and Stability samples.
• Lead technical Laboratory Incidents, Investigations and Problem Solvings.
• Lead local change controls and participate as a laboratory SME for changes in the network which impact the laboratory.
• Author, Review and Approve technical writing activities such as Protocols, Reports and procedures.
• Participate and lead Continuous improvement and Laboratory transformation projects.
• Support Divisional, Regulatory and EHS audits as an SME in your area on site.
• Play a key role in the troubleshooting and escalation process on site.
• Calibrate and maintain all designated laboratory instruments.
• Follow up-to-date practices with reference to pharmacopoeias, specifications, regulations and industry standards.
• Ensure training is current for all job functions performed.
• Maintain data integrity and ensure compliance with company SOPs, specifications and cGMP regulations.
• Ensure that cGMP standards are maintained at all times.
• Promote and participate the implementation and maintenance of the relevant safety programmes.
• Maintain MPS/Lean Lab standards within the laboratory.
• Support with various QC related Initiatives.
• Maintain good housekeeping and hygiene within the laboratory.

What skills you will need:

In order to excel in this role, you will more than likely have:

• A bachelor’s degree (or higher) in Natural Science/Chemical Engineering/Biological Engineering.
• Minimum 4-7 years’ experience in the pharmaceutical industry.
• Experience in performing Laboratory testing with a good understanding of relevant Analytical techniques.
• Experience in Technical writing (Investigations, Procedures, Change Controls etc.)
• Project participation and leading experience.
• Experience in participating in audits as an SME (Subject Matter Expert)
• Working knowledge of Six Sigma and Lean methodologies.
• Knowledge of GMP practices.
• A working knowledge of ICH guidelines and global pharmacopeial requirements.
• Experience using laboratory software (Empower 3, LIMS, SAP etc.)

So, if you are ready to:

Current Contingent Workers apply

Not Applicable

*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.