QC Senior Microbiology Analyst

County Meath, Ireland | Posted on 05/14/2024

• Industry Pharma/Biotech/Clinical Research
• Work Experience 5+ years
• City County Meath
• State/Province Meath
• Country Ireland

Job Description

About PSC Biotech

Who we are?

PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.

‘Take your Career to a new Level’

PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling point which includes the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diverse-cultural work setting.

Employee Value Proposition

Employees are the “heartbeat” of PSC Biotech, we provide unparalleled empowering career development though Learning & Development in-house training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our client’s expectations with regards to quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met.

Anamazing opportunity has arisen for a QC Senior Microbiology Analyst. Theorganisational structure at the site is based on self-directed work teams wheredecisions will be made at the level where the data exists.

TheSenior QC Microbiology Analyst will work across the site self-directed workteams and hub teams to identify and resolve issues to allow the site to deliveron our commit culture that support Quality, EHS, Learning and Continuousimprovement. The Senior Analyst will be responsible for supporting MicrobiologyLaboratory/Plant Start-up and sustaining/run the business activities at the newsingle use multi-product biotech facility in Dunboyne, County Meath, Ireland.

Theoverall responsibility for this role will be to support the MicrobiologyQuality Control testing function, ensuring compliance with cGMP and corporateregulations. This is a critical role within the Quality organisation to helpestablish the Laboratories as a hub for specialised analytical testing andcreate value for our patients.

Requirements

Whatyou will do:

Bringenergy, knowledge, innovation, and leadership to carry out the following:

• Conducting microbiology analysisincluding bioburden testing, endotoxin testing, microbial identification,Biological Indicator testing, BacT/ALERT testing, sterility checks, andgrowth promotion of media as required.
  
• Carry out environmental monitoringincluding viable and non-viable particulate monitoring in cleanroom areasof the manufacturing facility.
  
• Utility (water and gas) systemmonitoring.
  
• Participate in the technical transfer /validation / verification of microbiological and analytical testingprocedures.
  
• Train and support members of the team inmicrobiological test methods.
  
• Support the site aseptic training programand contamination control strategy of the facility to ensure the highestlevel of quality and practices in support of our patients.
  
• Ensure that all cGMP, companyspecifications, procedures and guidelines are followed.
  
• Investigate Out of Specification (OOS)and Out of Trend (OOT) results as required.
  
• Investigate Non-Conformances and activelylead subsequent corrective actions as required.
  
• Own and support CAPAs.
  
• Own and support Change Controls andChange Actions.
  
• Support Audit Readiness and participatein Audits.
  
• Support Commissioning QualificationValidation activities as required.
  
• Support and participate in Quality RiskAssessments.
  
• Support instrument calibration andmaintenance as required.
  
• Perform GEMBA Walks of the laboratory andcleanroom areas.
  
• Adhere to site documentation practicesand prepare and review document change requests as required.
  
• Use Global LIMS/MODA or othercomputerized systems for entering and approving test results asapplicable. Support system builds.
  
• Scheduling and coordinating the QCMicrobiology lab activities.
  
• Review and approval of QC data.
  
• Supporting analytical instrumentqualification.
  
• Coaching and mentoring the team.
  
• Leading/supporting projects and on-timeproject delivery.
  
• Trouble shooting and problem-solving.
  
• Drive Key Performance Indicators.
  
• Proven ability through working acrossteams focusing on meeting and tracking to schedules and embracing andinterdependent work culture as an agile team member.
  
• Promoting a culture where diversity andinclusion is part of the DNA.
  
• Collaborates with cross-functional teamsto deliver the site objectives.
  
• Work under minimal supervision and on owninitiative.
  

WhatSkills you will need:

Toexcel in this role, you will more than likely have:

• Minimum of a bachelor’s Level 8 degree ina technical discipline (e.g. microbiology, biochemistry, chemistry) orequivalent.
  
• Ideally 5 years’ experience working inMicrobiology in the pharmaceutical industry, preferably in a Biologicscompany.
  
• Coordination and organizational skills –Ability to manage multiple priorities and projects and escalate issues forresolution where required.
  
• Excellent problem-solving skills.
  
• Proven record of accomplishments in aregulated industry.
  
• Experience of plant microbiology andcontamination control, microbiology testing and method validation.
  
• Excellent communication skills (writtenand oral).
  
• Strong knowledge of cGMP requirements formanufacturing and/or systems and compliance.
  
• Required to work on his/her owninitiative, as part of a team and proven leadership skills.
  
• Demonstrated ability to coach teammembers to promote a high performing team.
  
• Demonstrated ability to give and receivefeedback.
  
• Demonstrated understanding of continuousquality / process improvement tools (As defined by the site, e.g. DMIAC, 8Step problem solving, 5S, MPS etc).