QA Compliance Microbiologist

We are currently recruiting for the role of QA Compliance Microbiologist within the QA Cleanroom Compliance department. The successful candidate will provide quality oversight to ensure adherence to all aspects of cleanroom behaviours, gowning, aseptic technique, cleaning & disinfection, transfer procedures and facility standards for classified cleanrooms in line with regulatory requirements. The successful candidate will also support with training, evaluation and continuous improvement projects within our aseptic cleanrooms. This role will involve working a 3 shift pattern including days, evenings and nights.

Main Activities/Tasks

• Work closely with cleanroom team to ensure alignment with best aseptic practices, standard operating procedures and GMP requirements.
• Participating in regular cleanroom inspections to promote continuous improvement and compliance.
• Quickly identifying and documenting all deficiencies found during cleanroom inspections and support with assessing risk to product.
• Initiating and supporting remediation measures and investigations required in response to the cleanroom inspections finding and environmental monitoring trends.
• Arrange & deliver initial training for personnel working in the classified cleanroom environment.
• Arrange & deliver periodic re-training in line with SOP & regulatory requirements and/or in response to environmental monitoring trends.
• Assisting in the reviewing and compilation of Standard Operation Procedures and other technical documentation in line with current GMP and regulatory requirements.
• Support with the selection and validation of new cleanroom cleaning, disinfectant, cleanroom consumable products e.g., mops, wipes, garments, stationary.
• Provide technical support for new and upgraded classified cleanroom facilities and cleanroom equipment.
• Support simplification & efficiency initiatives.
• Participate in customer and regulatory audits. 
• Be flexible to take any other duties as required by Management.

Essential Criteria:
Applicants must therefore demonstrate the following essential criteria on their application form be considered:

• Educated to at least Degree level or equivalent in a biological science or engineering field or have minimum 2 years’ experience within a high-grade cleanroom environment.
• Excellent attention to detail and highly organised.
• Strong computer skills and proficient in the use of Microsoft Office with the ability to generate reports.
• Flexibility to work a shift pattern which may incorporate nights and/or weekends.
• Excellent oral and written communication skills.

Desirable Criteria:
Applicants must therefore demonstrate the following essential criteria on their application form be considered:

• Practical experience of good aseptic technique in a manufacturing cleanroom.
• A minimum of 1 years’ experience in a training role.
• Prior experience of troubleshooting, performing investigations and preparing for regulatory inspections / customer audits.
• Good knowledge of cleanroom design; current good manufacturing practice; environmental monitoring requirements for aseptic processing facilities.
• Prior auditing experience.

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Duration: Full Time, Permanent

This role will involve working a 3 shift pattern:

Monday to Friday 6am-2pm
Monday to Friday 2pm-10pm
Sunday night to Friday morning 10pm-6am

The first 8-12 weeks training will be Monday to Friday 9am-5pm

Location: Newry

Benefits:

• Free Life Assurance
• Company Pension - salary sacrifice scheme
• Healthcare cash plan
• 32 days annual leave
• Wedding Leave
• Company Sick Pay
• Company Maternity / Paternity
• Paid bereavement leave
• Cycle to Work Scheme