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.
Summary:
The Quality Control (QC) Systems Specialist supports the QC Laboratory through routine maintenance, troubleshooting and repairs of all analytical laboratory instruments, in addition to supporting the instrument lifecycle (installation, qualification, operation, and retirement).
Additionally, the QC Systems Specialist supports the management of software application such as Empower, LabX and Signals, and any requests relating to these systems.
The QC Systems Specialist leads continuous improvement of QC operations, through their QC Systems knowledge and areas of expertise.
The QC Lab System team ensures that QC objectives are effectively achieved and consistent with requirements to ensure compliance, safety, and reliable supply to our customers.
This is a 12 Month Contract role.
Role Functions:
The QC Maintenance Instrumentation Specialist roles and responsibilities include but are not limited to the following:
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Responsible for the planned and unplanned maintenance of the QC systems and instrumentation, in compliance with up-to-date data integrity, regulatory, and industry standards
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Responsible for change control process and mechanisms required to maintain a state of continued compliance for the QC systems and instrumentation.
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Serve as site co-ordinator for software applications such as Empower, LabX and Signals.
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Support the QC department as a Super User and complete method requests as required.
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Support the QC department for troubleshooting, investigations, and deviations as an SME.
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Manage deviations, CAPA’s and change control’s related to QC systems and instrumentation and team priorities.
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Author and revise local SOPs, work instructions, and guidelines.
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Serve as an SME for regulatory and internal inspections and audits.
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Motivation to be an inspiring member of a high performing team with the desire to continuously learn, improve, and develop.
Experience, Knowledge & Skills:
Technical:
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Strong experience with analytical instrument maintenance, CSV experience beneficial.
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Experience using software applications such as Empower.
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Excellent understanding of data integrity compliance requirements.
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Demonstrated ability to drive complex tasks to completion.
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Strong organizational, problem-solving, and continuous improvement skills.
Business:
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Ability to prioritize activities in line with the maintenance schedules and business needs.
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Ability to maintain the flexibility to react to changing business needs and priorities.
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Experience and understanding of the change management requirements of validated systems and software.
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Excellent communication skills both verbal and written.
Leadership:
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Ability to handle multiple projects and deliver on critical deadlines.
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Demonstrated ability to work independently on own initiative and manage time.
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Demonstrate ability to work with a team and co-ordinate work to meet a common goal.
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A high level of self-motivation, knowledge, enthusiasm, and drive.
Qualifications:
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Third level education in a Science or Engineering related course of study
