QC Lead Analyst – Quality Operations Laboratory

PSC Biotech Corporation; Carlow; On-site; EUR 70,000 - 90,000; Full time

Job summary

PSC Biotech Corporation in Carlow, Ireland, is seeking a QC Lead Analyst to join the Quality Operations Laboratory. You will lead analytical testing such as ELISA and HPLC, drive cGMP compliance, and support method transfers and validations for key drug products.

The role requires 4+ years in a pharma lab, experience with compendial testing, and a strong track record in data integrity, investigations, and audits. The team operates in a two-cycle shift pattern with occasional travel for training.

Qualifications

• Bachelor's degree or higher in Analytical Chemistry/ Biochemistry or related field.
• 4+ years of experience in a pharmaceutical laboratory.
• Working knowledge of HPLC systems and software.
• Knowledge of ELISA and SoftMax Pro software is desirable.
• Strong understanding of cGMP, GLP, and Quality Management Systems.

Responsibilities

• Work as directed by QC Manager following cGMP and cGLP policies.
• Participate in QC Tier 1 daily meetings and communicate testing progress.
• Write/revise operational procedures and training materials.
• Operate as part of QC team performing testing and review.
• Perform analytical techniques including ELISA/HPLC/Compendial assays.
• Peer review testing documentation and ensure data integrity.
• Support OOS investigations and audits/inspections.
• Drive continuous improvement using root cause analysis tools.
• Promote a safe and compliant laboratory culture.

Skills

cGMP

ELISA

HPLC

Data integrity

QA documentation

Education

Bachelor's degree in Analytical Chemistry or Biochemistry

Tools

HPLC systems

SoftMax Pro

Compendial testing

Job description

QC Lead Analyst – Quality Operations Laboratory

• Industry Pharma/Biotech/Clinical Research
• Work Experience 4-5 years
• City Carlow
• State/Province Carlow
• Country Ireland

Job Description

About PSC Biotech

Who are we?

PSC Biotech is a leading Biotech Consultancy firm foundedin 1996, headquartered in Pomona, California, USA, with Global operations inIreland, India, Singapore, Australia and the US, serving 350 clients in morethan 23 countries worldwide. We provide cloud-based software solutions forQuality Management and Regulatory Inspections, pharmaceuticals contractmanufacturing professionals, and metrology services to our clients.

‘Take your Career to a new Level’

PSC Biotech disrupts the conventional consultancy modelby aligning our EVP as one of the unique selling point which includes theopportunity to work with the most talented cohort of like-minded professionalsoperating in the Pharma/ Biotech Industry. We offer a permanent contract ofemployment giving exposure of working in Top Pharmaceutical client sites in adiverse-cultural work setting.

Employee Value Proposition

Employees are the “heartbeat” of PSC Biotech, we provideunparalleled empowering career development though Learning & Developmentin-house training mentorship through constant guidance to facilitate careerprogression. We believe in creating high performing teams that can exceed ourclient’s expectations with regards to quality of all scalable and business unitdeliverables, staying under budget and ensuring timelines for our deliverablesare being met.

Overview:

• Join a supportive, growing team in the analysis ofBiologics and Vaccines in a state-of-the-art Quality Operations laboratory,manufactures and tests biggest selling biologic and the biggest selling vaccineproduct and is a strategic manufacturing site.
  
• The QC Lead Analyst will report directly to the QCManager and will help us in the expansion of this Laboratory and completeanalytical method transfers and validation as well as commercial testing. Theteam works a 2-cycle shift pattern.
  
• Occasional travel may be required for training purposes.
  
• The ideal candidate will have 4+ year’s experience in apharmaceutical laboratory, ideally with experience in ELISA/HPLC/CompendialTesting and relevant systems and software. Core to the role is to performtesting of samples to support the release of our key drug products.
  

Requirements

What you will do:

• Work as directed by the Quality Control Manager accordingto Company safety policies, cGMP and cGLP. Required to drive compliance withGlobal policies, procedures and guidelines and regulatory requirements andexecute Good Manufacturing Practices (cGMP) in the performance of day-to-dayactivities and all applicable job functions
  
• Participate in QC Tier 1 daily meetings and ensureeffective communication of testing progress, deviations etc
  
• Participate in writing/revising/ rolling out accurateoperational procedures, training materials and maintenance procedures forvarious Quality systems; ensure all work is carried out in line with same
  
• Operate as part of the QC team performing the allocatedtesting and review
  
• Perform various analytical techniques including but notlimited ELISA/HPLC/Compendial Assays in compliance with GMP requirements
  
• Peer review testing documentation and ensuring dataintegrity compliance and QC Right First Time KPIs are achieved
  
• Participate in the laboratory aspects of OOSinvestigations
  
• Provide support with audit/inspection requirements toensure department compliance/readiness.
  
• Participate in internal and external audits andinspections, taking the role of auditee for assigned areas of responsibility.
  
• Drive continuous improvement, perform root cause analysison system failures and substandard equipment performance, using standard toolsand methods, to resolve machine and system issues e.g., FMEA, Fishbonediagrams, 5 why's etc,
  
• Work collaboratively to drive a safe and compliantculture
  

What skills you will need:

• Bachelors Degree or higher preferred; ideally inAnalytical Chemistry/ Biochemistry or a closely related discipline
  
• 4+ years of experience in a pharmaceutical laboratory
  
• A good working knowledge of HPLC systems and software isdesirable
  
• A good working knowledge of ELISA and Softmax Prosoftware is desirable
  
• A good knowledge of cGMP, GLP, Quality Management Systems