QA Compliance Microbiologist

Job Overview

​​​​​​​QA Compliance Microbiologist required within our QA Cleanroom Compliance department. You 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. You will also support with training, evaluation and continuous improvement projects within our aseptic cleanrooms. 

Main Activities/Tasks

• Ensure alignment with best aseptic practices, standard operating procedures and GMP requirements.
• Participating in cleanroom inspections, promoting continuous improvement and compliance.
•  Identifying and documenting all deficiencies found during inspections and support with assessing risk to product.
• Initiating and supporting remediation measures and investigations in response to 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 reviewing and compilation of Standard Operation Procedures and other technical documentation in line with current GMP and regulatory requirements.
• Support with 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. 

Essential Criteria:

• 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:

• 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.

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

Additional Information:

• This role will be based in a site that produces and handles penicillin, and as such, this role would not be suitable for those that have a penicillin allergy.
• Applicants should be able to provide proof that they have a right to work in the UK at the time of their application. Applicants who are unable to provide this proof will not be considered.

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
• Tech Purchase Scheme
• Employee Savings scheme
• Employee well-being initiatives
• Employee Assistance Programme
• On-site free parking
• Subsidised Canteen Facilities
• Employee Perks scheme
• Employee Recognition scheme
• Career development opportunities