Associate Quality Control Specialist

1 month ago

Carlow, Ireland PSC Biotech Ltd Full time
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 looking for an Associate Quality Control Specialist as part of the Incoming Quality team at site reporting to the Quality Control Manager.
  • You will support all aspects of New Material Introduction process and associated supplier changes ensuring effective interaction with other departments/global teams on matters related to new material introduction and associated qualification as well as support selection and management of external testing Laboratories ensuring all outsourced methods are validated and suitable for the product/material required.


Requirements

Role Functions:

  • Work as directed by the Quality Control Manager according to Company safety policies, cGMP and cGLP
  • Facilitate and drive effective communication to ensure success through representation of QC team on tier meetings
  • Support all aspects of New Material Introduction process ensuring effective interaction with other departments/global teams/ external contract testing labs on matters related to new material introduction, supplier changes and associated qualification
  • Participate and support Internal/External Investigations
  • Coordinate the creation/ update to Quality standards for raw materials and components . Complete impact assessments for change controls related to processes
  • Coordinate any efficiency/ increased Lab capability projects as detailed by Quality Control Manager
  • Provide support with audit/inspection requirements to ensure department compliance/readiness. Participate in internal and external audits and inspections, taking the role of auditee for assigned areas of responsibility
  • Coordination, ownership, and author as required for Annual Product Review
  • Participate in Quality Risk Management

Experience, Knowledge & Skills:

  • 2-4 years of experience in a cGMP laboratory environments
  • Knowledge of or previous experience in New Material Introduction process
  • Proficiency in Microsoft Office and job related computer applications required
  • Good communication, interpersonal skills and ability to work across teams
  • Demonstrated ability to drive the completion of tasks
  • Demonstrated ability to solve problems/perform investigations
  • Method validation and method transfer experience would be advantage

 

Qualifications & Education:

  • Bachelor’s degree or higher preferred; ideally in Chemistry, analytical chemistry or a related Science discipline or relevant experience 
#LI-AM1

Requirements
2-4 years of experience in a cGMP laboratory environments Knowledge of or previous experience in New Material Introduction process Coordinate the creation/ update to Quality standards for raw materials and components . Complete impact assessments for change controls related to processes

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