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 PropositionEmployees 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:As QC Bioassay Analyst you will perform and review a
range of techniques such as immunoassays, cell based potency bioassays and
aseptic techiniques as part of routine and non-routine testing and project
work to ensure processes and end products comply with corporate and regulatory
requirements to facilitate product release. Reporting to the Bioassay Manager /
Associate Director you will ensure that objectives are effectively achieved,
consistent with our requirements to ensure compliance, safety and reliable
supply to our customers.Our Quality Assurance group ensures every single material
inside our products is manufactured, processed, tested, packaged, stored and
distributed aligned with our incredibly high standards of quality and meets all
regulatory requirements. Partnering
across our internal manufacturing facilities, external contract manufacturers
and suppliers we create an interdependent global manufacturing network
committed to deliver a compliant, reliable supply to customers and patients on
time, every time, across the globe.RequirementsResponsibilities:Work as directed by the Bioassay Manager / Associate
Director, according to Company safety policies, cGMP and cGLP.Required to drive compliance with our Global policies,
procedures and guidelines and regulatory requirements and execute Good
Manufacturing Practices (cGMP) in the performance of day to day activities and
all applicable job functions.Required to comply with our 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.Develop, implement and maintain procedures that comply
with appropriate regulatory requirements.Ensure that all Quality Systems within the department are
adhered to on a daily basis.Operate as part of the QC team performing the allocated
testing and laboratory-based duties.Ensure timely completion of all assigned data processing
and reviewing.Ensure timely completion of Laboratory Investigation
Reports and deviations through site proceduresParticipate in the timely generation of trend data,
investigations, nonconformances, validation protocols, reports in support of
method validation/verifications and equipment qualifications.Participate in QC Tier 1 daily meetings and ensure
effective communication of testing progress, deviations etc.Peer review testing documentation and ensuring data
integrity compliance and QC Right First Time KPIs are achieved.Where applicable, review, approve and trend test results.Participate in the laboratory aspects of OOS
investigations.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.Drive continuous improvement, perform root cause analysis
on system failures and substandard equipment performance, using standard tools
and methods, to resolve machine and system issues e.g. FMEA, Fishbone diagrams,
5 why's etc,Work collaboratively to drive a safe and compliant
culture.May be required to perform other duties as assigned. Skills & Knowledge:Technical:Knowledge of regulatory/ code requirements to Irish,
European and International Codes, Standards and Practices.Knowledge of cGMPLaboratory Quality SystemsProficiency in Microsoft Office and job-related computer
applications requiredReport, standards, policy writing skills requiredUnderstanding of Lean Six Sigma Methodology preferred.Immunoassay and cell culture experience preferable People:A great communicator, decisive decision-maker with a
proven ability to deliver excellenceAbility to participate in highly-effective teams.The desire to continuously learn, improve and develop.Strong leadership and interpersonal skills.Willingness to support the team and a strong focus on
delivering excellence.High personal integrity, credibility, energy and
flexibility.Model the leadership behaviours and use the MPS
principles to achieve success.Set clear performance standards; overcome obstacles; hold
ourselves and others accountable for achieving results. Education:Bachelor’s Degree or higher preferred; ideally in a
science related discipline. Reports to :Bioassay Manager / Associate Director #LI-EL1