QC Bioassay Analyst

• Industry Pharma/Biotech/Clinical Research
• Work Experience 1-3 years
• City Carlow
• State/Province Carlow
• Country Ireland

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 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.

Job Title: QC Bioassay Analyst

Role Description

· Our Site has an immediate opportunity for anumber of QC Bioassay Analyst to join our Quality Operation Laboratory. Youwill operate as part of the QC team performing the allocated testing andlaboratory-based duties and although it is preferable that Analysts haveImmunoassay and cell culture experience, we are open to considering applicantsthat fulfil the duties as detailed below.

· Reporting to the Bioassay Manager / AssociateDirector, the team is working a 2-cycle shift pattern of 7am-3pm and 3pm-11pm(Monday-Friday) rotating weekly

· Our Quality Assurance group ensures every singlematerial inside our products is manufactured, processed, tested, packaged,stored and distributed aligned with our incredibly high standards of qualityand meets all regulatory requirements.Partnering across our internal manufacturing facilities, externalcontract manufacturers and suppliers we create an interdependent globalmanufacturing network committed to deliver a compliant, reliable supply to customersand patients on time, every time, across the globe.

Role Functions:

· Perform and review a range of techniques such asimmunoassays, cell-based potency bioassays and aseptic techniques as part ofroutine and non-routine testing and project work to ensure processes and endproducts comply with corporate and regulatory requirements to facilitateproduct release.

· Work as directed by the Bioassay Manager /Associate Director, according to Company safety policies, cGMP and cGLP.

· Required to drive compliance with our Globalpolicies, procedures and guidelines and regulatory requirements and executeGood Manufacturing Practices (cGMP) in the performance of day-to-day activitiesand all applicable job functions.

· Required to comply with our Global Policies,Procedures and Guidelines, regulatory requirements and execute current GoodManufacturing Practices (cGMP) in the performance of day-to-day activities andall applicable job functions.

· Ensure that all Quality Systems within thedepartment are adhered to on a daily basis.

· Operate as part of the QC team performing theallocated testing and laboratory-based duties.

· Ensure timely completion of all assigned dataprocessing and reviewing.

· Ensure timely completion of LaboratoryInvestigation Reports and deviations through site procedures.

· Participate in the timely generation of trenddata, investigations, nonconformances, validation protocols, reports in supportof method validation/verifications and equipment qualifications.

· Participate in QC Tier 1 daily meetings andensure effective communication of testing progress, deviations etc.

· Peer review testing documentation and ensuringdata integrity compliance and QC Right First Time KPIs are achieved.

· Review, approve and trend test results whereapplicable,

· Participate in the laboratory aspects of OOSinvestigations.

· Provide support with audit/inspectionrequirements to ensure department compliance/readiness.

· Drive continuous improvement, perform root causeanalysis on system failures and substandard equipment performance, usingstandard tools and methods, to resolve machine and system issues e.g. FMEA,Fishbone diagrams, 5 why's etc,

· May be required to perform other duties asassigned.

Experience, Knowledge & Skill:

· Knowledge of regulatory/ code requirements toIrish, European and International Codes, Standards and Practices.

· Knowledge of cGMP

· Laboratory Quality Systems experience

· Proficiency in Microsoft Office and job-relatedcomputer applications required

· Report, standards, policy writing skillsrequired

· Understanding of Lean Six Sigma Methodologypreferred.

· Immunoassay and cell culture experiencepreferable

· Great communicator, decisive decision-maker witha proven ability to deliver excellence

· Ability to participate in highly effectiveteams.

· Desire to continuously learn, improve anddevelop.

· Willingness to support the team and a strongfocus on delivering excellence.

· High personal integrity, credibility, energy andflexibility.

Qualifications & Education:

· Bachelor’s Degree or higher preferred; ideallyin a science related discipline.