Quality Control Technician

PSC Biotech® Corporation; Carlow; On-site; EUR 35,000 - 55,000; Full time

Job summary

PSC Biotech in Ireland is seeking a Technician, Quality Control to support CGMP activities and ensure data integrity in GLIMS-based workflows. The role involves end-to-end sample lifecycle management, QA collaboration, and driving continuous improvement within a multi-site pharma environment.

The candidate will liaise with QC leads, maintain compliant processes, and contribute to root-cause investigations while assisting with batch releases and cross-functional quality initiatives.

Qualifications

• Experience with a LIMS (GLIMS experience is an advantage).
• Strong communicator, comfortable working with stakeholders at all levels.
• Able to prioritise and deliver against competing deadlines.
• Collaborative and able to communicate effectively across functions.
• Committed to continuous improvement and operational excellence.

Responsibilities

• Liaise with the QC Leads to resolve quality related queries where required.
• Ensure that adequate processes and procedures are in place and followed for all Quality activities.
• Provide support to the relevant support functions to ensure manufacturing and release activities, in compliance with applicable procedures, our Company’s Global Policies and Guidelines, regulatory requirements and current Good Manufacturing Practices (cGMP).
• Develop and maintain effective cross-functional relationships with other departments and support functions to ensure that the process for the manufacturing, testing and release of vaccine and biologic products are in compliance with cGMP and the associated regulatory requirements.
• Identify and support compliance initiatives to improve compliance status and overall operational efficiency for batch release at the site.
• Support business critical projects related to the Quality Department.
• Responds to standard requests and communication processes to allow the flow of appropriate information between departments.
• Use MPS principles and tools to identify and support continuous improvement by active participation to ensure quality systems and work practices are effective, efficient and ensure compliance and overall operational efficiency for batch and material release at the site where required.
• Sign approved job description.
• Support in resolving routine potential quality issues.
• Provide quality support of controls and procedures for the end to end material and product lifecycle where applicable.
• Assist team members to support the qualification/validation, technical transfers, and commercial operations at the facility where required.
• Support the Sample Management team members completing day to day activities, as applicable.
• Ensure compliance to regulatory requirements.
• Assist team members with tasks relating to SOP's, Deviations and other documents as necessary for the Quality and Manufacturing departments where required.
• Contribute to effective writing/revising/rolling out of accurate operational procedures, training materials and maintenance procedures for various Quality related systems.
• Participate in training programs as required.

Skills

Strong communicator

Prioritise and deliver deadlines

Collaborative

Continuous improvement

Education

Leaving Certificate or equivalent experience

Tools

GLIMS

LIMS experience

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.

Technician, Quality Control

• Comply with and execute CGMP/GDP in the performance of day-to-day business activities.
• Ensure data integrity principles: Attributable, Legible, Contemporaneous, Original, and Accurate (ALCOA) are adhered to for records and data in day-to-day business activities.
• Attend and successfully complete applicable CGMP training.
• Escalate any potential violation of CGMP and/or other concerns which may affect the safety, efficacy, quality, or purity of human health products.
• Work collaboratively to ensure a safe and compliant culture
• Participate in driving a high performing s inclusive culture, stimulating personal growth s development may be required to perform other duties as assigned.
• Coordinate the end-to-end sample lifecycle in GLIMS: receipt, logging, processing, distribution and traceability through to disposal.
• Prioritise and schedule sample workload to meet timelines
• Coordinate shipment of samples to external contract laboratories and sister sites
• Log retain samples in accordance with retain sample management programme
• Ensure day-to-day activities meet GMP and regulatory standards
• Contribute to root cause investigations using structured problem-solving tools
• Identify and deliver continuous improvement projects that improve efficiency and reliability
• Partner with Manufacturing, QC, Quality Assurance, External Quality and other stakeholders to meet site goals

Requirements

About You:

• Experience with a LIMS (GLIMS experience is an advantage)
• Strong communicator, comfortable working with stakeholders at all levels
• Able to prioritise and deliver against competing deadlines
• Collaborative and able to communicate effectively across functions
• Committed to continuous improvement and operational excellence

Responsible for activities including some or all of the following and any other tasks as required:

Quality

• Liaise with the QC Leads to resolve quality related queries where required
• Ensure that adequate processes and procedures are in place and followed for all Quality activities.
• Provide support to the relevant support functions to ensure manufacturing and release
• activities, in compliance with applicable procedures, our Company’s Global Policies and Guidelines, regulatory requirements and current Good Manufacturing Practices (cGMP).
• Develop and maintain effective cross-functional relationships with other departments and support functions to ensure that the process for the manufacturing, testing and release of vaccine and biologic products are in compliance with cGMP and the associated regulatory requirements.
• Identify and support compliance initiatives to improve compliance status and overall operational efficiency for batch release at the site.
• Support business critical projects related to the Quality Department.

Delivery

• Responds to standard requests and communication processes to allow the flow of appropriate information between departments.
• Use MPS principles and tools to identify and support continuous improvement by active participation to ensure quality systems and work practices are effective, efficient and ensure compliance and overall operational efficiency for batch and material release at the site where required.
• Sign approved job description.

Site Business Area Support

• Support in resolving routine potential quality issues.
• Provide quality support of controls and procedures for the end to end material and product lifecycle where applicable.
• Assist team members to support the qualification/validation, technical transfers, and commercial operations at the facility where required.

Quality Control

• Support the Sample Management team members completing day to day activities, as applicable.

Compliance Responsibilities

• Ensure compliance to regulatory requirements.
• Assist team members with tasks relating to SOP's, Deviations and other documents as necessary for the Quality and Manufacturing departments where required.
• Contribute to effective writing/revising/rolling out of accurate operational procedures, training materials and maintenance procedures for various Quality related systems.

Other

• Participate in training programs as required.

Typical Minimum Education

• Leaving Certificate or other relevant experience.