Immunoassays, Cell Culture (use of cells to execute bioassays) and
Aseptic Technique?
The is a contract role based on site in Dun Laoghaire, Dublin.
If you have the relevant experience, please forward your CV to **Apply
on the website** for review or call * **Apply
on the website** to discuss in confidence.
QC ANALYST - BIOASSAYS - 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 into
Ireland&# *;s leading aseptic manufacturing
plant.
Under minimal supervision, responsible for one or more of the
following activities in QC including: Reagent management, media
preparation, GMP document review and management, sample and data
management and some analytical testing.
Contributes to team by ensuring the quality of the tasks/services
provided by self.
Contributes to the completion of milestones associated with specific
projects or activities within team
The role undertakes implementing continuous improvement projects and
supporting a lean culture and Right First Time (RFT).
The role also represents the QC unit by liaising with internal and
external customers.
With a high degree of technical flexibility, work across diverse areas
within the lab
Plan and perform routine tasks with efficiency and accuracy.
Review, evaluate, back-up/archive, and approve analytical data.
Troubleshoot, solve problems and communicate with stakeholders.
Participate in audits, initiatives, and projects that may be
departmental or organizational in scope.
Evaluate lab practices for compliance and operational excellence
improvement on a continuous basis.
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
Demonstrated ability to work independently and deliver right first
time results
Works under minimal direction
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.
Recognizes and escalates problems
Demonstrated leadership and communication skills
Auditing documentation and operation process
Demonstrated ability to interact with regulatory agencies.
REQUIREMENTS
Bachelor’s degree in a Biochemistry or Biology discipline.
2+ years of biopharmaceutical QC experience or related quality control
or GMP laboratory experience in the pharmaceutical or medical device
industry.
Experience with regulatory compliance in cGMP manufacturing and
testing of pharmaceutical products.
Understanding and application of principles, concepts, theories and
standards of GMP QC analytical laboratories.
Deepens technical knowledge through exposure and continuous learning
Knowledge of related regulatory/industry considerations, compliance
issues and/or scientific discovery
Some / limited experience in a wide variety of analytical techniques
including but not limited to Cell-Based Potency Bioassays,
Immunoassays, Cell Culture and Aseptic Technique
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
Project Management and organizational skills, including ability to
follow assignments through to completion
PACKAGE
Contract role - Hourly rate € * - €**Apply
on the website** per hour
The initial contract duration * months with
view to extend
Work location: Onsite requirement is 5 days a week as this is a
lab-based role.
There are no shift requirements.
The core working hours are *:**Apply on the
website** to *: *.
We need : English (Good)
Type: Permanent
Payment: EUR 20 - 27 Per Hour
Category: Construction
