Quality Control Lead Analyst, Biochemistry and Cell Biology
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Quality Control Lead Analyst, Biochemistry and Cell Biology
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Job Description
A fantastic opportunity has arisen for a
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 culture that accommodates rapid growth and highly dynamic expectations, ensuring attainment of site operational and development goals.
* Perform a variety of routine Biochemistry and Cell Biology analytical testing techniques and associated documentation; including but not limited to ELISA, PCR, Bioassays and Cell Culture, water and cleaning validation sample testing and compendial methods in compliance with GMP requirements.
* Perform advanced assays requiring precise analytical skills and an understanding of biological and chemical 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 other work teams to increase efficiency, solve problems, generate cost savings, improve quality, and provide new product support.
* Provide support and expertise for the preparation of regulatory submissions, inspection readiness, health authority inspections including interaction with inspectors, responses to inspection observations, and monitoring of follow up actions.
* Support activities including general lab readiness, audit readiness, laboratory equipment qualification and analytical method technical transfer, verification and validation.
* Champion site metrics to ensure targets are achieved, met and counter measures in place when applicable.
* 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 improvement behaviours 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 BEFORE the 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
Seniority level
* Seniority level
Not Applicable
Employment type
* Employment type
Full-time
Job function
* Job function
Quality Assurance
* Industries
Biotechnology Research, Pharmaceutical Manufacturing, and Veterinary Services
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