Job Description
A fantastic opportunity has arisen for a Quality Control Lead Analyst (Biochemistry and Cell Biology) in our Dunboyne facility. This individual will be responsible for quality control testing related to Biochemistry and Cell Biology in Dunboyne biologics.
Bring energy, knowledge, innovation to carry out the following:
* Develop and coach the Quality Control team and drive a high-performance organisational culturethat accommodates rapid growth and highly dynamic expectations, ensuring attainment of siteoperational and development goals.
* Perform a variety of routine Biochemistry and Cell Biology analytical testing techniques andassociated documentation; including but not limited to ELISA, PCR, Bioassays and Cell Culture,water and cleaning validation sample testing and compendial methods in compliance with GMPrequirements.
* Perform advanced assays requiring precise analytical skills and an understanding of biological andchemical principles.
* Complete special project/protocol testing in a timely manner under direction of Project Leads and/or Area Lead.
* Contribute to a team setting within the laboratory and project activities and potentially with otherwork teams to increase efficiency, solve problems, generate cost savings, improve quality, andprovide new product support.
* Provide support and expertise for the preparation of regulatory submissions, inspection readiness,health authority inspections including interaction with inspectors, responses to inspectionobservations, and monitoring of follow up actions.
* Support activities including general lab readiness, audit readiness, laboratory equipmentqualification and analytical method technical transfer, verification and validation.
* Champion site metrics to ensure targets are achieved, met and counter measures in place whenapplicable.
* Consistently deliver on specific area Key Performance Indicators.
* Operate to the highest standards of Safety, Quality, and Compliance.
* Provide immediate feedback to others at any time to reinforce good safety and improvementbehaviours and acts.
* Provide coaching for the team members as part of the continuous improvement mindset.
* Role model the behaviours that creates a culture of dignity and respect.
* Responsible for being a designee for the people lead as required
* Lead projects as required
What skills you will need:
In order to excel in this role, you will more than likely have:
* A degree qualification in Science/Quality/Technical disciplines.
* Minimum 4 years’ experience in the biotechnology and/or pharmaceutical industry, (preferably both) •
* Leadership skills and experience managing daily activities.
* Preferably Lean Six Sigma experience.
* Excellent written and oral communication skills.
* Strong understanding of cGMP requirements for manufacturing and/or systems and compliance.
* Required to work on their own initiative in a constructive manner in addition to working as part of a team.
* Excellent time management and organisational skills.
* Strong understanding of biochemical and cell biology methodology (ELISA, SDS-Page, Bio-Assays, PCR, and compendial assays, e.g. pH, Appearance, TOC etc) and strong technical skills.
* Strong understanding of GMP, ICH, USP and global compendia regulations and guidance's, particularly as related to analytical method development and validation.
* Experience with continuous quality/process improvement tools (As defined by the site, e.g. DMAIC,Lean QA, 5S etc).
* Excellent trouble shooting and problem solving skills.
* Ability to think logically and be proactive under pressure.
* Flexible and self-motivated.
* Ability to challenge the status quo with a continuous improvement mindset.
* Promoting a culture where diversity and inclusion is part of the DNA
As a company, we are committed to keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare needs.
As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. Please don't hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process.
We are committed to flexible working where possible, and this is why our Company has introduced a new hybrid working model for office-based colleagues around the world.
Please feel free to speak to us about what flexibility means to you during your application.
So, if you are ready to:
Invent solutions to meet unmet healthcare needs, please apply today.
Current Employees apply HERE
Current Contingent Workers apply HERE
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Regular
Relocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Not Applicable
Shift:
Valid Driving License:
Hazardous Material(s):
Required Skills:
Analytical Instrumentation, Analytical Instrumentation, Animal Husbandry, Assay, Biochemical Assays, Biological Analysis, Cell-Based Assays, Cell Cultures, Cell Physiology, Chemical Analysis, Clinical Data Interpretation, Communication, Equipment Maintenance, GMP Compliance, Hazardous Waste Disposal, Hazardous Waste Management, Hazardous Wastes, Inventory Management, Laboratory Safety, Mammalian Cell Culture, Management Process, Microbiological Analysis, Personal Initiative, Polymerase Chain Reaction (PCR), Qualitative Testing {+ 5 more}
Preferred Skills:
Job Posting End Date:
07/7/2025
*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID:R350193
#J-18808-Ljbffr