QC Documentation Coordinator

Orion Group Life Sciences are currently recruiting a QC Documentation Coordinator on behalf of our Multinational Biopharmaceutical Client based in Carlow on an initial 11-Month contract with potential to extend.

Functions:

• Be a document system expert for the Quality Control Department; this will include document generation and review and document system work-flow expedition where applicable - examples include Standard Operation Procedures, Work Instruction, Policies, Safety procedures, Annual Product Reviews, electronic logs.
• Format, write and deliver necessary documentation in line with Merck Global Policies, Procedures and Guidelines, regulatory requirements.
• Support laboratory administration activities through documentation generation, documentation filing, tracking and auditing.
• Manage and complete department specific assignments, including periodic review of documents.
• Support continuous improvement by active participation and engagement with laboratory team for document updates out of investigations and corrective actions.
• Contribution to Kaizen events and documentation improvement projects as appropriate.
• Ensure timely completion of all assigned documents to meet site metric requirements.
• Work collaboratively to drive a safe and compliant culture in Carlow.
• Participate in QC daily meetings and ensure effective communication of assigned tasks/projects etc.

Education/Qualifications

Typical Minimum Education:

• Degree preferred; ideally in a related discipline

Typical Minimum Experience:

• Experience and/or a particular skill set in their area of expertise that adds value to the Business, preferably GMP setting.

Technical:

• Proficiency in Microsoft word, Office, excel and electronic data management systems
• Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices
• Report, standards, policy writing skills required
• Understanding of Lean Six Sigma Methodology preferred

Business:

• Excellent communication, presentation and interpersonal skills, to interface effectively with all levels of colleagues and with external customers, in a team orientated manner
• Ability to work with teams and escalate issues to management in a proactive manner
• Customer service
• Goal/results orientated
• Training skills
• Effective time management and multi-tasking skills
• Proven organizational skills
• Excellent attention to detail
• Self-motivated
• Flexible approach
• Planning and scheduling skills

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.