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QC Micro Analyst
Orion Group are looking for a QC Micro Analyst for our multinational pharmaceutical client based in the Cork area on an initial 12-month contract with the potential to extend.
Main Responsibilities of the role
Reporting to the QC Team Leader the person will be responsible for the following;
- Performing a wide variety of microbiology, chemistry or biochemistry testing to support utilities, raw material, in process, bulk and drug product release
- Rapid turnaround of samples to meet manufacturing needs
- Performing data review and approval
- Providing support and advice to manufacturing on QC related topics
- Initiating and leading investigations where required
- Initiates and completes, CAPAs and Change Controls in accordance with site procedure
- Writes new and updates current procedures on electronic documentation system
- Providing training to other analysts and to manufacturing personnel
- Presents technical analytical data clearly and concisely data to customers, i.e., internal investigations and regulatory inspectors etc.
- Proactively identifies and implements lab process improvements
- Supports lean initiatives in the area of lab operations, i.e. standard work, level loading, test method execution, documentation updates and equipment qualification etc.
Desired Experience and Background of the successful candidate
- The position of QC analyst requires a third-level qualification (Minimum: Primary degree in a science discipline)
- A minimum of 2 years' experience within the Pharmaceutical Industry
- Knowledgeable of FDA/EMEA regulatory requirements applicable to pharmaceuticals and aseptic products
- Superior technical knowledge of analytical techniques and knowledge of related laboratory equipment in the area of microbiological, chemistry and biochemistry testing of Bulk API and final drug product
- Must have prior experience of working in an IMB/FDA regulated facility
- Preferred Testing Experience:
-Microbial Identification using genetic methods
- Adaptable and flexible
- Maintains the highest standards of ethical behaviour
- Clear communication skills
- Holds self-accountable for compliant and flawless execution
- Experience with electronic systems such as LIMS, Electronic Lab notebooks, Empower, Trackwise etc.
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.
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