Are you an QC Analyst with experience of Cell based- Bioassays, 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 ****** for review or call 353 1 7978720 to discuss in confidence.QC Analyst - Bioassays - DublinJob 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 teamThe 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 labPlan 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 resultsMay participate in lab investigations.May provide technical guidance.May train others.May contribute to regulatory filings.May represent the department/organization on various teamsMay interact with outside resourcesDemonstrated ability to work independently and deliver right first time resultsWorks under minimal directionWork is guided by objectives of the department or assignmentFollows proceduresRefers to technical standards, principles, theories and precedents as neededMay set project timeframes and priorities based on project objectives and ongoing assignments.
Recognizes and escalates problemsDemonstrated leadership and communication skillsAuditing documentation and operation processDemonstrated ability to interact with regulatory agencies.RequirementsBachelor'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 learningKnowledge of related regulatory/industry considerations, compliance issues and/or scientific discoverySome / limited experience in a wide variety of analytical techniques including but not limited to Cell-Based Potency Bioassays, Immunoassays, Cell Culture and Aseptic TechniqueTake initiative to identify and drive improvementsExcellent verbal and written communication skillsStrong Technical writing skills for GMP documentation (e.g.
investigations, procedures, change controls)Presentation skillsEscalate issues professionally and on a timely basisDecision Making skillsTeamwork and Coaching othersNegotiation and Influence skillsProject Management and organizational skills, including ability to follow assignments through to completionPackageContract role - Hourly rate €20 - €27 per hourThe initial contract duration 12 months with view to extendWork 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 08:30 to 17:00.
