Associate Specialist Quality Control-Microbiology

PSC Biotech Corporation; Carlow; On-site; EUR 52,000 - 72,000; Full time

Job summary

PSC Biotech is seeking an Associate Specialist in Quality Control - Microbiology to provide technical support to the QC Microbiology Lab and operations in Carlow, Ireland. The role focuses on environmental monitoring, trend analysis, and ensuring compliance with regulatory/compendial requirements.

You will lead risk assessments, trend reporting, method development, and participate in continuous improvement initiatives while ensuring high safety standards and timely project delivery in a GMP

Qualifications

• Bachelor’s degree in Microbiology, Biology, Biotechnology, Pharmaceutical Science, or a related Life Sciences field.
• Minimum 3 years of hands-on experience in microbiology/QC, especially environmental monitoring and utilities monitoring.
• Ability to author procedures, change controls, deviations, reports, and work in line with regulatory/compendial requirements.
• Strong troubleshooting, decision-making, and ability to drive improvements such as lean lab initiatives and method optimization.
• Familiarity with ALCOA(+) data integrity, electronic lab systems, and controlled documentation.

Responsibilities

• Support the environmental control program by trend analysis and implementing corrective and preventive measures.
• Own environmental monitoring risk assessments and qualification activities.
• Generate quarterly and annual trend reports.
• Interpret regulatory/compliance and compendial requirements and stay updated on changes.
• Develop and execute microbiology test methods and project validations.
• Troubleshoot issues during validation studies and routine tests.
• Develop training modules.
• Provide microbiology support to site investigations related to environmental monitoring and utilities.
• Drive continuous improvement including lean lab initiatives and method optimization.
• Author and manage change controls, procedures, test methods and deviations.

Skills

Environmental monitoring

Trend analysis

Regulatory compliance

Troubleshooting

Method development

Documentation

Education

Bachelor’s degree in Microbiology or Life Sciences

Tools

LIMS

ELN/LIMS integration

GLIMS

Job description

Associate Specialist Quality Control-Microbiology

• Industry Pharma/Biotech/Clinical Research
• Work Experience 4-5 years
• City Carlow
• State/Province Carlow
• Country Ireland

Job Description

About PSC Biotech

Who are we?

PSC Biotech is a leading Biotech Consultancy firm foundedin 1996, headquartered in Pomona, California, USA, with Global operations inIreland, India, Singapore, Australia and the US, serving 350 clients in morethan 23 countries worldwide. We provide cloud-based software solutions forQuality Management and Regulatory Inspections, pharmaceuticals contractmanufacturing professionals, and metrology services to our clients.

‘Take your Career to a new Level’

PSC Biotech disrupts the conventional consultancy modelby aligning our EVP as one of the unique selling point which includes theopportunity to work with the most talented cohort of like-minded professionalsoperating in the Pharma/ Biotech Industry. We offer a permanent contract ofemployment giving exposure of working in Top Pharmaceutical client sites in adiverse-cultural work setting.

Employee Value Proposition

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

Overview:

• We are seeking an Associate Specialist Quality Control toprovide technical support to the QC Microbiology Lab & operations to ensurethe continued manufacture and supply of quality pharmaceutical products inmeeting the priorities of: Compliance, Supply, Strategy and Profit Plan. Thisrole is integral to our manufacturing division and requires a high level ofleadership, initiative, collaboration, and coaching to facilitate the team inbecoming a high-performance organization. If you are passionate about drivingcontinuous improvement and delivering technical excellence, we invite you tojoin our company and make a difference in advancing health solutions.
  
• Experience in supporting operations projects withknowledge of regulatory and global compliance requirements. The ideal candidatemust have the ability to own and manage projects and deliver on requiredtimelines.
  

Requirements

Key Responsibilities

• Supporting the environmental control program by trendanalysis and implementation of appropriate corrective and preventativemeasures.
  
• Supporting and owner of Environmental monitoring riskassessments and qualification.
  
• Generation of quarterly and annual trend reports.
  
• Understanding and applying regulatory/compliance andcompendial requirements to their role together with remaining current onupcoming regulatory and compliance changes.
  
• Development and execution of Microbiology test methodsand project validations.
  
• Troubleshooting of issues which arise during theexecution of validation studies and routine tests.
  
• Development of training modules.
  
• Microbiology Support to Site Investigations and projectsrelating to environmental monitoring and utilities monitoring.
  
• Driving Continuous Improvement initiatives, includinglean lab initiatives, method optimization/redevelopment.
  
• Authoring and managing change controls, procedures, testmethods and deviations.
  
• Result authorization for microbiological samples tosupport batch release.
  
• GLIMS System updates.
  
• Assessing compendial and quality manual updatespertaining to the Microbiology Lab & environmental control.
  
• Supporting lab stock management and financial control asrequired.
  
• Interpreting customer needs, assessing requirements, andidentifying solutions to non-standard requests.
  
• Making decisions within guidelines and policies whichimpact microbiology projects.
  
• Ensuring highest safety standards.
  
• Performing other duties as assigned.
  

Qualifications:

Required

• Bachelor’s degree in Microbiology, Biology,Biotechnology, Pharmaceutical Science, or a related Life Sciences field.
  
• Minimum 3 years of hands-on experience inmicrobiology/QC, specifically in environmental monitoring and utilitiesmonitoring, supporting site projects, trending, risk assessments, and dataanalysis.
  
• Ability to author procedures, change controls,deviations, reports, and work in line with regulatory/compendial requirements.
  
• Strong troubleshooting, decision-making, and ability todrive improvements such as lean lab initiatives and method optimization.
  
• Strong microbiology background and strong understandingof aseptic processing, environmental monitoring programs, and contaminationcontrol in sterile manufacturing.
  
• Experience in a GMP QC laboratory with knowledge ofregulatory expectations.
  
• Familiarity with ALCOA(+) data integrity principles,electronic laboratory systems, and controlled documentation.
  
• Entry- to early-career level with growing technicalcompetence; able to perform routine tasks with limited discretion.
  

Preferred:

• Experience with problem solving, decision making,scheduling of laboratory testing/tasks