Sr.
Tech, Quality Control page is loaded## Sr.
Tech, Quality Controlremote type: Not Applicablelocations: IRL - Carlow - Carlowtime type: Full timeposted on: Posted Todaytime left to apply: End Date: April 27, **** (12 days left to apply)job requisition id: R******Job DescriptionA fantastic opportunity has arisen for a **QC Analyst.
**Join a supportive, growing team in the analysis of Biologics and Vaccines in a state-of-the-art Quality Operations laboratory.
Carlow will manufacture and test biggest selling biologic and the biggest selling vaccine product and is a strategic manufacturing site.The **QC Analyst / Senior Technician Quality Control** will report directly to the QC Manager and will help us in the expansion of this Laboratory and complete analytical method transfers and validation as well as commercial testing.The lab operates a 2 cycle and 4 cycle shift and roles are available in both.Occasional travel may be required for training purposes.
**Bring energy, knowledge, innovation to carry out the following:*** Work as directed by the Quality Control Manager according to Company safety policies, cGMP and cGLP.
Required to drive compliance with Global policies, procedures and guidelines and regulatory requirements and execute Good Manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions* Participate in QC Tier 1 daily meetings and ensure effective communication of testing progress, deviations etc* Participate in writing/revising/ rolling out accurate operational procedures, training materials and maintenance procedures for various Quality systems; ensure all work is carried out in line with same* Operate as part of the QC team performing the allocated testing and laboratory-based duties* Perform various analytical techniques including but not limited to HPLC, (HIC, CE, IEX, HP-SEC), Capillary Electrophoresis and other compendial test methods in compliance with GMP requirements* Peer review testing documentation and ensuring data integrity compliance and QC Right First Time KPIs are achieved* Participate in the laboratory aspects of OOS investigations* Provide support with audit/inspection requirements to ensure department compliance/readiness.
* Participate in internal and external audits and inspections, taking the role of auditee for assigned areas of responsibility.
* Drive continuous improvement, perform root cause analysis on system failures and substandard equipment performance, using standard tools and methods, to resolve machine and system issues e.g., FMEA, Fishbone diagrams, 5 why's etc,* Work collaboratively to drive a safe and compliant culture on site.
**What skills you will need:**In order to excel in this role, you will more than likely have:* Bachelors Degree or higher preferred; ideally in Analytical Chemistry/ Biochemistry or a closely related discipline* The ideal candidate will have 2- 3 year's experience in a pharmaceutical laboratory, ideally with experience in HPLC and relevant systems and software.
Core to the role is to perform testing of samples to support the release of our key drug products.
* A good working knowledge of HPLC systems and software is desirable* A good knowledge of cGMP, GLP, Quality Management SystemsThe Carlow site broke ground in **** and is a filling site for the launch and commercial supply of vaccines, biologics, and small molecule drug product.
Since its initial launch, the site has attracted significant internal investment and is now home to a number of state-of-the-art production facilities, laboratories, and temperature-controlled warehousing units.
The Carlow site is a significant employer in the South East region and attracts high performing talent through close collaborations with universities and colleges in the region.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.
**Required Skills:**Analytical Method Transfer, GMP Compliance, GMP Laboratory, Laboratory Analytical Techniques, Laboratory Information Management System (LIMS), Laboratory Investigations, Laboratory Operations, OOS Investigations, Quality Control Management, Sterility Testing, Technical Procedures**Preferred Skills:**Current Employees applyCurrent Contingent Workers apply**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:**No relocation**VISA Sponsorship:**No**Travel Requirements:**10%**Flexible Work Arrangements:**Not Applicable**Shift:**Not Indicated**Valid Driving License:**No**Hazardous Material(s):**Yes**Job Posting End Date:**04/27/2026**\*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.
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