PE Global is currently recruiting QC Technician - Micro on behalf of our client based in Carlow:
11 month initial contract- with 20% Shift Premium – 2 shift patterns
This role will be a mix of testing and documentation
• Perform any assigned aspect of routine testing in support of manufacturing and batch release with high quality of documentation Right First Time.
• Documentation updates, deviation writing, technical writing, trend report data review checks
• Clearly demonstrate the organisational skills to manage day to day tasks
• Ensure SOPs/forms are followed at all times
• Work as part of a team and alone
• Demonstrate awareness of safety for self and others in all aspects of work
• Understand analysis of data generated in the lab, importance of Data integrity
• Maintain laboratory housekeeping standards
• Strong scientific and GMP documentation skills
• Comply with Global and regulatory Requirements and execute current good manufacturing practices (cGMP) in the performance of day to day activities and all applicable job functions
• May be required to perform other duties as assigned.
Specific tests to be performed in the lab are below, will not be trained on all at once of course, focus area will be determined based on experience and business needs upon start date and will progress into other tests within the lab as competence is shown.
Previous experience in the below is considered a strong advantage:
* Growth promotion testing of incoming media
* pH testing
* Maldi-TOF identification testing (strong advantage if experience here)
* Utilities sampling (WFI Utilities, Pre-treatment, clean steam sampling)
* Biological Indicator testing
* Bioburden testing
* Plate reading and enumeration
* Sample receipt and sample management
Responsibilities:
* Performs QC assignments for Carlow quality systems, processes and controls.
* Accountable for contribution to ensure that objectives are effectively achieved, consistent with requirements to ensure compliance, safety & reliable customer supply.
* Responds to Operational and business areas, ensuring compliance with cGMP and corporate regulations.
* Support the performance of the site cGMP activities.
Key Responsibilities:
* Comply with and execute CGMP/GDP in the performance of day-to-day business activities.
* Ensure data integrity principles: Attributable, Legible, Contemporaneous, Original, and Accurate (ALCOA) are adhered to for records and data in day-to-day business activities.
* Attend and successfully complete applicable CGMP training.
* Escalate any potential violation of CGMP and/or other concerns which may affect the safety, efficacy, quality, or purity of human health products.
* Work collaboratively to ensure a safe and compliant culture in Carlow.
* Participate in driving a high performing & inclusive culture, stimulating personal growth & development.
* May be required to perform other duties as assigned.
Educational and Experience Requirements
* Bachelors Degree or higher preferred; ideally in a related Science discipline
* 3- 5 years relevant experience
How to Apply
Interested candidates should submit an updated CV. Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland.
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