QC Microbiology Analyst

Orion Group Life Sciences are currently recruiting a QC Microbiology Analyst on behalf of our Multinational Pharmaceutical Client based in Little Island, Cork on an initial 12-Month contract with potential to extend.

POSITION SUMMARY:
This position is responsible for carrying out tasks and projects related to bulk solvent, utility, in process, release and sterility testing of pharmaceutical products as required by Good Manufacturing Practice (GMP).

GENERAL SCOPE OF RESPONSIBILITIES:

• Achieves a high level of competency in laboratory methods and procedures to support testing activities.
• Performs routine and non-routine Microbiological testing activities as required.
• Ensures that all testing is completed, reviewed and approved within agreed turnaround times.
• Ensures QC activities are carried out in compliance with product license commitments, cGMP and company quality standards.
• Trains other QC analysts and Manufacturing personnel in laboratory methods and procedures when required.
• Writes/updates and reviews TMDs, SOPs and WIs as required.
• Writes and reviews Quality Issues and Investigations as required.
• Is an active member of the QC group and aid with other group activities as required.
• Communicates relevant issues to the QC Team Leader promptly.

SPECIFIC TESTING EXPERIENCE REQUIRED

• Bioburden
• Endotoxin
• Environmental Monitoring
• Growth Promotion
• Sterility

OTHER RESPONSIBILITIES / DETAILED DUTIES MAY APPLY:

• Maintains and develops knowledge of analytical technology as well as cGMP standards.
• Partners with other departments to ensure that all QC testing activities are completed in a compliant and efficient manner.

KEY COMPETENCIES REQUIRED:

• Excellent interpersonal skills.
• Ability to operate as part of a team is critical.
• Excellent communication skills both written and verbal.
• Good knowledge of LIMS, Track wise and electronic documentations systems.
• Experience working in a high throughput laboratory environment.
• Excellent technical writing skills.
• Customer focus.
• Attention to detail.
• Good problem-solving skills.
• Results and performance driven.
• Adaptable and flexible.
• Ability to prioritise work based on strict sample hold times and customer needs.
• Experience in utilising root cause problem solving tools.

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.