QC laboratory Specialist

About PSC Biotech

Who we are

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 cloudbased 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 points which includes the opportunity to work with the most talented cohort of likeminded 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 diversecultural work setting.

Employee Value Proposition

Employees are the heartbeat of PSC Biotech we provide unparalleled empowering career development though Learning & Development inhouse 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.

Role Description

• This is a contract based role for a QC Laboratory Technician as part of the Incoming Quality team at Carlow. The successful candidate will be responsible for supporting the Incoming quality team in the areas of sample management primary pack inspection cleaning analysis.
  
• Building key relationships with both internal and external stakeholders.
  
• Complete all duties in compliance with GMP and GxP standards.
  
• Client is expanding site and this is an excellent opportunity.
  

Requirements

Responsibilities

• Movement of materials across the companys network
  
• System transactions including movement and shipping of samples across QC labs within the network.
  
• Knowledge and experience using systems such as GLIMS LIMS and SAP beneficial.
  
• Inspection of primary packaging
  
• Participate in writing/revising/ rolling out accurate operational procedures training materials and maintenance procedures for various Quality systems; ensure all work is carried out in line with same.
  
• Where applicable review approve and trend test results.
  
• Peer review other analysts documentation ensuring QC Right First Time KPIs are achieved.
  
• Participate in QC daily meetings and ensure effective communication of testing progress deviations etc.
  
• Ensure that all Quality Systems within the department are adhered to on a daily basis.
  
• Complete all documentation in compliance with GMP and GxP standards.
  
• Problem solving to get to root cause of issues.
  
• Provide support with audit/inspection requirements to ensure department compliance/readiness.
  
• Collaborating with others by sharing your skillset and expertise
  
• Drive continuous improvement perform root cause analysis on system failures e.g. FMEA Fishbone diagrams 5 whys etc
  
• Drive compliance with Companys Global Policies Procedures and Guidelines regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions including maintenance of accurate records.
  

Requirements

• 1 3 years experience in the Pharmaceutical Biopharmaceuticals industry or a similar operating environment which includes experience in a Quality function
  
• Previous Analytical Experience
  
• Demonstrated ability to work independently and fully realize improvement initiatives with a moderate level of guidance
  
• Good communication interpersonal skills and ability to work across teams.
  

Education

• Degree in Science Engineering or similar
  

#LIAK1

Responsibilities Movement of materials across the company's network System transactions including movement and shipping of samples across QC labs within the network. Knowledge and experience using systems such as GLIMS, LIMS and SAP beneficial. Inspection of primary packaging Participate in writing/revising/ rolling out accurate operational procedures, training materials and maintenance procedures for various Quality systems; ensure all work is carried out in line with same. Where applicable, review, approve and trend test results. Peer review other analysts documentation, ensuring QC Right First Time KPIs are achieved. Participate in QC daily meetings and ensure effective communication of testing progress, deviations etc. Ensure that all Quality Systems within the department are adhered to on a daily basis. Complete all documentation in compliance with GMP and GxP standards. Problem solving to get to root cause of issues. Provide support with audit/inspection requirements to ensure department compliance/readiness. Collaborating with others by sharing your skill-set and expertise Drive continuous improvement, perform root cause analysis on system failures e.g. FMEA, Fishbone diagrams, 5 why's etc, Drive compliance with Company's Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions, including maintenance of accurate records. Requirements 1 - 3 years experience in the Pharmaceutical, Biopharmaceuticals industry or a similar operating environment which includes experience in a Quality function Previous Analytical Experience Demonstrated ability to work independently and fully realize improvement initiatives with a moderate level of guidance Good communication, interpersonal skills and ability to work across teams. Education Degree in Science, Engineering or similar #LI-AK1