performing Endotoxin, sterility, Bioburden, Water utility monitoring
and Lab Support duties?
This is a contract role based in Dun Laoighaire, South Dublin.
If interested, forward your CV to * or call
Karen on + *- * for a
confidential chat.
MICROBIOLOGY QC ANALYST - BIOTECH LAB - DUBLIN
JOB DESCRIPTION
Our client is a leading international Biotechnology company with a
state of the art aseptic manufacturing facility in Dun Laoighaire,
South Dublin.
The plant is one of the most dynamic in Ireland and is currently
undergoing rapid expansion and capital investment.
This is an excellent opportunity to get experience on Ireland&#**Apply
on the website**;s leading aseptic manufacturing plant.
Under minimal supervision, successful candidate would be responsible
for one or more of the following activities in QC including
microbiological testing, method transfers, sample and data management
and equipment maintenance.
This role is for an experienced and technically strong associate who
will spend *% of their work day performing
testing.
The successful candidate would contribute to team by ensuring the
quality of the tasks/services provided by self and contribute to the
completion of milestones associated with specific projects or
activities within team.
This role will support manufacturing operations, as such some extended
hours, shift and weekend work may
Endotoxin testing of water, in-process and drug product release
samples
Bioburden testing of water & in-process drug product samples
Sterility testing
Water sampling
Lab Support duties such as Biological Indicator testing, Growth
Promotion, Media Preparation, Identifications and Autoclave.
Writing technical reports
Perform analytical testing as a main priority with efficiency and
accuracy
With a high degree of technical flexibility, work across diverse areas
within the lab
Plan and perform multiple routine/ non-routine methods and procedures
with a large variety of assays.
Report, evaluate, archive, trend and approve analytical data.
Troubleshoot, solve problems and communicate with stakeholders.
Initiate and/or implement changes in controlled documents.
Participate in audits, initiatives, and projects that may be
departmental or organizational in scope.
Write protocols and perform assay validation.
Introduce new techniques to the lab, including method transfers,
reports, validations and protocols.
Evaluate lab practices for compliance and operational excellence
improvement on a continuous basis.
Review and Approve lab results
May participate in lab investigations.
May provide technical guidance.
May train others.
May contribute to regulatory filings.
May represent the department/organization on various teams
May interact with outside resources
REQUIREMENTS
Bachelors degree in a science discipline
Biopharmaceutical QC experience in a microbiology lab
Experience with regulatory compliance in cGMP manufacturing and
testing of pharmaceutical products
Preferred Qualifications
Experience working in endotoxin, bioburden or sterility testing
Proficient in GMP systems such as LIMS Labware & LMES
Experience in a wide variety of microbiological techniques, including
but not limited to Bioburden, Endotoxin, Sterility (in an Isolator),
Rapid Micro techniques, Microbial Identification, Media prep, Water
Sampling.
Understanding and application of principles, concepts, theories and
standards of GMP QC microbiology laboratories.
Deepens technical knowledge through exposure and continuous learning
Knowledge of related regulatory/industry considerations, compliance
issues and/or scientific discovery Skills
Take initiative to identify and drive improvements
Excellent verbal and written communication skills
Strong Technical writing skills for GMP documentation (e.g.
investigations, procedures, change controls)
Presentation skills
Escalate issues professionally and on a timely basis
Decision Making skills
Teamwork and Coaching others
Negotiation and Influence skills
Problem solving skills
Applies research, information gathering, analytical, and
interpretation skills to problems of diverse scope
Ensures compliance within regulatory environment
Develops solutions to technical problems of moderate complexity
Screens, categorizes, evaluates, reconciles, reports, and resolves
data integrity issues
Interprets generally defined practices and methods
Technically strong background in microbiology and aseptic
manufacturing
Experience in LIMS, Change Control, Trackwise, SAP and CDOCS an
advantage
Flexibility – the role often encounters changing priorities (also
required to work weekend on call – Rota system)
Demonstrated ability to work independently and deliver right first
time results
Works under minimal direction, Recognizes and escalates problems
Work is guided by objectives of the department or assignment
Follows procedures
Refers to technical standards, principles, theories and precedents as
needed
May set project timeframes and priorities based on project objectives
and ongoing assignments.
PACKAGE
Hourly rate € * - € *
per hour
Contract role
Minimum * month contract
The role requires the candidate to be onsite five days a week, the
core days and hours are Monday to Friday from **Apply on the
website**: * to *:**Apply
on the website**.
In addition there are on-call weekend (Sat and Sun) and this happens
every 9 weeks.
We need : English (Good)
Type: Permanent
Payment: EUR 25 - 34 Per Hour
Category: Construction
