21373-QC Senior Microbiology Analyst-Meath Contractor

This is an 11-month contract. Role will be shift based – 12/7

Purpose 

The Senior QC Microbiology Analyst will work across the site self-directed work teams and hub teams to identify and resolve issues in order to allow the site to deliver on our commit culture that support Quality, EHS, Learning and Continuous improvement. The Senior Analyst will be responsible for supporting Microbiology Laboratory/Plant Start-up and sustaining/run the business activities at the new single use multi-product biotech facility in Dunboyne, County Meath, Ireland.

The overall responsibility for this role will be to support the Microbiology Quality Control testing function, ensuring compliance with cGMP and corporate regulations. This is a critical role within the Quality organisation to help establish the Laboratories as a hub for specialised analytical testing and create value for our patients.

Responsibilities

• Conducting microbiology analysis including bioburden testing, endotoxin testing, microbial identification, Biological Indicator testing, BacT/ALERT testing, sterility checks, and growth promotion of media as required.
• Carry out environmental monitoring including viable and non-viable particulate monitoring in cleanroom areas of the manufacturing facility.
• Utility (water and gas) system monitoring.
• Participate in the technical transfer / validation / verification of microbiological and analytical testing procedures.
• Train and support members of the team in microbiological test methods.
• Support the site aseptic training program and contamination control strategy of the facility to ensure the highest level of quality and practices in support of our patients.
• Ensure that all cGMP, company specifications, procedures and guidelines are followed.
• Investigate Out of Specification (OOS) and Out of Trend (OOT) results as required.
• Investigate Non-Conformances and actively lead subsequent corrective actions as required.
• Own and support CAPAs.
• Own and support Change Controls and Change Actions.
• Support Audit Readiness and participate in Audits.
• Support Commissioning Qualification Validation activities as required.
• Support and participate in Quality Risk Assessments.
• Support instrument calibration and maintenance as required.
• Perform GEMBA Walks of the laboratory and cleanroom areas.
• Adhere to site documentation practices and prepare and review document change requests as required.
• Use Global LIMS/MODA or other computerized systems for entering and approving test results as applicable. Support system builds.
• Scheduling and coordinating the QC Microbiology lab activities.
• Review and approval of QC data.
• Supporting analytical instrument qualification.
• Coaching and mentoring the team.
• Leading/supporting projects and on-time project delivery.
• Trouble shooting and problem-solving.
• Drive Key Performance Indicators.
• Proven ability through working across teams focusing on meeting and tracking to schedules and embracing and interdependent work culture as an agile team member.
• Promoting a culture where diversity and inclusion is part of the DNA.
• Collaborates with cross-functional teams to deliver the site objectives.
• Work under minimal supervision and on own initiative.

Requirements 

• Minimum of a bachelor’s Level 8 degree in a technical discipline (e.g. microbiology, biochemistry, chemistry) or equivalent.
• Ideally 5 years’ experience working in Microbiology in the pharmaceutical industry, preferably in a Biologics company.
• Coordination and organizational skills – Ability to manage multiple priorities and projects and escalate issues for resolution where required.
• Excellent problem-solving skills.
• Proven record of accomplishments in a regulated industry.
• Experience of plant microbiology and contamination control, microbiology testing and method validation.
• Excellent communication skills (written and oral).
• Strong knowledge of cGMP requirements for manufacturing and/or systems and compliance.
• Required to work on his/her own initiative, as part of a team and proven leadership skills.
• Demonstrated ability to coach team members to promote a high performing team.
• Demonstrated ability to give and receive feedback.
• Demonstrated understanding of continuous quality / process improvement tools (As defined by the site, e.g. DMIAC, 8 Step problem solving, 5S, MPS etc).