Associate Specialist Quality Control

Job Information

Date Opened

05/25/2026
Job Type

Full time
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 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.

Overview:

We are seeking an Associate Specialist Quality Control to provide technical support to the QC Microbiology Lab \& operations to ensure the continued manufacture and supply of quality pharmaceutical products in meeting the priorities of: Compliance, Supply, Strategy and Profit Plan. This role is integral to our manufacturing division and requires a high level of leadership, initiative, collaboration, and coaching to facilitate the team in becoming a high\-performance organization. If you are passionate about driving continuous improvement and delivering technical excellence, we invite you to join our company and make a difference in advancing health solutions.

Experience in supporting operations projects with knowledge of regulatory and global compliance requirements. The ideal candidate must have the ability to own and manage projects and deliver on required timelines.

Requirements

Key Responsibilities:

• Supporting the environmental control program by trend analysis and implementation of appropriate corrective and preventative measures.


• Supporting and owner of Environmental monitoring risk assessments and qualification.


• Generation of quarterly and annual trend reports.


• Understanding and applying regulatory/compliance and compendial requirements to their role together with remaining current on upcoming regulatory and compliance changes.


• Development and execution of Microbiology test methods and project validations.


• Troubleshooting of issues which arise during the execution of validation studies and routine tests.


• Development of training modules.


• Microbiology Support to Site Investigations and projects relating to environmental monitoring and utilities monitoring.


• Driving Continuous Improvement initiatives, including lean lab initiatives, method optimization/redevelopment.


• Authoring and managing change controls, procedures, test methods and deviations.


• Result authorization for microbiological samples to support batch release.


• GLIMS System updates.


• Assessing compendial and quality manual updates pertaining to the Microbiology Lab \& environmental control.


• Supporting lab stock management and financial control as required.


• Interpreting customer needs, assessing requirements, and identifying solutions to non\-standard requests.


• Making decisions within guidelines and policies which impact microbiology projects.


• Ensuring highest safety standards.


• Performing other duties as assigned.

Required

• 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, specifically in environmental monitoring and utilities monitoring, supporting site projects, trending, risk assessments, and data analysis.


• 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.


• Strong microbiology background and strong understanding of aseptic processing, environmental monitoring programs, and contamination control in sterile manufacturing.


• Experience in a GMP QC laboratory with knowledge of regulatory expectations.


• Familiarity with ALCOA(\+) data integrity principles, electronic laboratory systems, and controlled documentation.


• Entry\- to early\-career level with growing technical competence; able to perform routine tasks with limited discretion.

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

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