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. RequirementsResponsibilities:Support laboratory operations within the new laboratory
facility which will include support of equipment qualification (PQ),
documentation generation of SOP’s, Work instructions as well as contributing to
lab and process establishment.Review, trending and reporting of laboratory data, to
support generation of batch data, maintain oversight of review metrics, to
collate and analyze end of quarter and year reports for all raw data generated.
Maintaining and release of laboratory stock, ordering laboratory consumables
where required.Manage and ensure routine cleans of laboratory equipment
are completed as per site procedures, ensure laboratory housekeeping standards
are maintained, identifying continuous improvement opportunities in laboratory
processes.Responds to standard requests from partners, customers,
and clients (internal and/or external).Active participation in functional meetings, facilitation
of cross-functional meetings where required.Participation in laboratory investigations and Root Cause
Analysis activities.Participation in internal and external audit and
inspection activities.Participation in SME development groups to improve
technical expertise.Support site safety culture.Perform supporting activities for general lab operations,
EM, Facility testing, method transfers, method verifications, and execution of
laboratory studies were required.A good knowledge of GMP, familiarity with USP, EP, JP
requirements.Support introduction of novel, innovative solutions,
supporting the testing of biologics within the facility.Participation in risk assessments as required.Ability to solve problems and take new perspectives on
existing solutions with a desire to continuously learn, improve and develop.Excellent troubleshooting and problem-solving skills as
an individual contributor as well as collaboration skills and teamworking
ability with global and interdisciplinary teams.Support Culture of the client ways of Working.Build team effectiveness skills, learn to promote team
success through own actions and by demonstrating respect and appreciation for
diverse populations.Support timely training completion and coaching of team
members.Be flexible to support changing business needs, (e.g.
Infrequent out of hours testing support for exceptional circumstances).Act as a group representative at cross-functional
meetings. Experience, Knowledge & Skills:Ability to work as part of a team and on own initiative
in a constructive manner.Knowledge with Biologics manufacturing and familiarity
with microbiological testing techniques.Knowledge of laboratory systems (e.g. LIMS, E-logs, MODA,
and electronic notebooks).Ability to think logically and be proactive under
pressure.Effective communicator and technical expertise in
science, to be able to share and communicate that knowledge through training
other analysts.To support site culture Qualification:A degree qualification in a relevant field (Biological
Sciences/ Engineering), preferable for background in microbiology.A minimum of 1-3 years experience working in a relevant
academic or industry field, (Internships and student placements will be
considered in lieu of experience).#LI-AM1