QC Bioassay Analyst – Quality Operations Laboratory

PSC Biotech Corporation; Carlow; On-site; EUR 40,000 - 55,000; Full time

Job summary

PSC Biotech Corporation in Ireland's Carlow is seeking a QC Bioassay Analyst to join our Quality Operations Laboratory. The role focuses on biologics and vaccines analysis, supporting release testing and method transfers in a GMP environment.

You will perform analytical techniques including HPLC, ELISA, and cell-based assays, contribute to data integrity, and participate in internal/external audits, with a 2-cycle shift pattern and occasional travel for training.

Qualifications

• Bachelor’s degree or higher in Analytical Chemistry, Biochemistry or closely related field.
• 2–3 years’ experience in a pharmaceutical laboratory, preferably with HPLC, cell-based assays and relevant systems/software.
• Working knowledge of Immunoassay, HPLC systems and software is desirable.
• Good knowledge of cGMP, GLP and Quality Management Systems.

Responsibilities

• Perform analytical testing and laboratory-based duties as part of the QC team.
• Write, revise and roll out accurate SOPs, training materials and maintenance procedures.
• Ensure data integrity and QC Right First Time KPIs are achieved.
• Participate in OOS investigations and audit/inspection readiness.
• Drive continuous improvement using root-cause analysis (FMEA, Fishbone, 5 Why) and troubleshoot instrument issues.
• Support internal and external audits and inspections as needed.

Skills

HPLC

Cell-based assays

Immunoassay

Cell culture

Capillary electrophoresis

Data integrity

GMP knowledge

Education

Bachelor's degree in Analytical Chemistry or Biochemistry

Tools

HPLC software

Cell culture equipment

Capillary electrophoresis instrumentation

Job description

QC Bioassay Analyst – Quality Operations Laboratory

• Industry Pharma/Biotech/Clinical Research
• Work Experience 1-3 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. OurQC group ensures every single material inside our products is manufactured,processed, tested, packaged, stored and distributed aligned with our incrediblyhigh standards of quality and meets all regulatory requirements.Partnering across our internal manufacturingfacilities, external contract manufacturers and suppliers we create an interdependentglobal manufacturing network committed to deliver a compliant, reliable supplyto customers and patients on time, every time, across the globe.
  
• The QC Analyst (Quality Operations) will report directlyto the QC Manager and will help us in the expansion of this Laboratory andcomplete analytical method transfers and validation as well as commercialtesting.
  
• This role follows a 2 cycle shift pattern, alternatingweekly: 7am - 3pm (week 1), 3pm-11pm (week 2).
  
• Occasional travel may be required for training purposes.
  

Requirements

Bring energy, knowledge, innovation to carry out thefollowing:

• 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 laboratory-based duties
  
• Perform various analytical techniques including but notlimited to HPLC, (HIC, CE, IEX, HP-SEC), ELISA, Cell Based Assay, Cell Culture,Capillary Electrophoresis and other compendial test methods in compliance withGMP requirements
  
• Peer review testing documentation and ensuring dataintegrity compliance and QC Right First Time KPIs are achieved
  
• Ensure timely completion of all assigned data processingand reviewing.
  
• 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 on site.
  

What skills you will need:

• Bachelors Degree or higher preferred; ideally inAnalytical Chemistry/ Biochemistry or a closely related discipline.
  
• The ideal candidate will have 2- 3 years’ experience in apharmaceutical laboratory, ideally with experience in HPLC / Cell based assaysand relevant systems and software. Core to the role is to perform testing ofsamples to support the release of our key drug products.
  
• A good working knowledge of Immunoassay, Cell Culture,HPLC systems and software is desirable
  
• A good knowledge of cGMP, GLP, Quality Management Systems