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:To perform day to day laboratory testing, data review,
routine duties and capable of enthusiastically taking responsibility for ad-hoc
duties and projects. While working co- operatively as part of a team, will
demonstrate drive, initiative and hunger for knowledge and quality of work.
Will be, or demonstrate the capability of being, a Subject Matter Expert in
several assays.Ensures that laboratory objectives are effectively
achieved consistent with requirements to ensure compliance, safety and reliable
supply to our customers.RequirementsRole Functions:Performs any assigned aspect of routine testing in
support of manufacturing and batch release with high quality of documentation
RFT and technical writingPerforms data review of microbiological test data from
utilities and environmental monitoring samples. Other data review may be
performed in line with experience level and SME knowledgeClearly demonstrates the organisational skills to manage
all aspects of a given assay e.g.; controls/reference, standard stock control
etc.Ensures SOPs/forms are up to date with latest
requirements and improvements/optimizations/lean.Supports process simulations Works as part of a teamDemonstrates awareness of safety for self and others in
all aspects of work. Understands analysis of data generated in the lab.Maintains laboratory housekeeping standardsMust have strong scientific and GMP documentation skills.Understands Pharmacopoeias and guidelines and how to find
and follow relevant informationRequired to comply with Global and regulatory
Requirements and execute current good manufacturing practices (cGMP) in the
performance of day to day activities and all applicable job functions.Work collaboratively to drive a safe and compliant
culture, may be required to perform other duties as assigned. Skills and Knowledge:Typical Minimum Education:Diploma or higher preferred; ideally in a related
discipline Typical Minimum Experience:Would typically have prior related work experience;
ideally in a Microbiology Laboratory setting Core Competences:Technical:Knowledge of cGMP and GDP preferredLaboratory Quality SystemsProficiency in Microsoft Office and job-related computer
applications requiredUnderstanding of Lean six Sigma Methodology preferred Business:Effective communication and interpersonal skills to
interface effectively with all levels of colleagues in a team environment, and
with external customersFlexible approach Leadership:Focus on Customers and PatientsCollaborateAct with Candor and CourageMake Rapid, Disciplined DecisionsDrive ResultsBuild TalentDemonstrate Ethics and Integrity Reports to: Microbiology laboratory ManagerShift Cycle: 2 Cycle Shift#LI-AM1