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:
Responsible for supporting the Quality Control Department in the management of external sample shipments and retain sample management. Support various administrative duties associated with sample management. Ensuring that objectives are effectively achieved to, consistent with requirements to ensure Compliance, safety and reliable supply to our customers. This is a Day role based on site (Mon-Fri)
Role Functions:
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Will act as point of contact for QC sample and retain management.
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Responsible for QC External sample management from receipt to shipment.
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Responsible for QC retain sample management from receipt to disposal.
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Knowledge and understanding of current Good Manufacturing Practices (cGMP) related to the QC Laboratory and ability to identify gaps in processes or systems.
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Proficient with using Microsoft Office applications (Outlook, Excel, Word, and PowerPoint).
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Proficient with Lab management software system (LIMS).
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Prepare documents and coordinate Sample movement within the Warehouse area.
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Review eLogs and/ or LIMs to align physical quantities of samples in freezers/refrigerators/lean lifts and sample cages.
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Take ownership of processes related to sample handling e.g. oversight of freezers/refrigerator clean schedule.
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Perform or support sample management related non-conformance investigations.
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Supports Internal and Regulatory Audits.
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Format, write and deliver necessary documentation in line with Global Policies, Procedures and Guidelines, regulatory requirements.
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Support continuous improvement by active participation and engagement with laboratory team during investigations and subsequent corrective actions.
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Ensure timely completion of all assigned documents to meet site metric requirements.
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Work collaboratively to drive a safe and compliant culture
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Participate in QC daily tier meetings and ensure effective communication of assigned tasks/projects.
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May be required to perform other duties as assigned.
Experience, Knowledge & Skills
Technical:
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Proficiency in Microsoft word, Office, excel and job-related computer applications required i.e. LIMS
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Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices
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Understanding of Lean Six Sigma Methodology preferred
Business:
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Excellent communication, presentation and interpersonal skills, to interface effectively with all levels of colleagues and with external customers, in a team orientated manner
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Ability to work with teams and escalate issues to management in a proactive manner.
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Planning and scheduling skills Customer service
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Goal/results orientated.
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Training skills
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Effective time management and multi-tasking skills
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Proven organizational skills.
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Excellent attention to detail
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Self-motivated
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Flexible approach
Qualifications & Education
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Third Level qualification preferred, ideally in a related discipline.
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Experience and/or a particular skill set in their area of expertise that adds value to the Business, preferably GMP setting.
