Job Description
A fantastic opportunity has arisen for aSpecialist Quality Control.
This role will provide technical support to the QC Microbiology Lab operations to ensure the continued manufacture and supply of quality pharmaceutical products in meeting the priorities of: Compliance, Supply, Strategy and Profit Plan. This role is integral to our manufacturing division and requires a high level of leadership, initiative, collaboration, and coaching to facilitate the team in becoming a high-performance organization. If you are passionate about driving continuous improvement and delivering technical excellence, we invite you to join our company and make a difference in advancing health solutions.
We are seeking an experienced specialist with hands on expertise in authoring and supporting risk assessment creations and updates, analysing trend data, trend report creations, owner and assessment of change controls and deviations impacting cleanroom contamination control. Experience in supporting operations projects with knowledge of regulatory and global compliance requirements. The ideal candidate must have the ability to own and manage projects and deliver on required timelines.
Bring energy, knowledge, innovation to carry out the following:
- Supporting the environmental control program by trend analysis and implementation of appropriate corrective and preventative measures.
- Supporting and owner of Environmental monitoring and utility sysems risk assessments and qualification.
- Generation of quarterly and annual trend reports.
- Understanding and applying regulatory/compliance and compendial requirements to their role together with remaining current on upcoming regulatory and compliance changes.
- Development and execution of Microbiology test methods and project validations.
- Troubleshooting of issues which arise during the execution of validation studies and routine tests.
- Development of training modules.
- Microbiology Support to Site Investigations and projects relating to environmental monitoring and utilities monitoring.
- Driving Continuous Improvement initiatives, including lean lab initiatives, method optimization/redevelopment.
- Authoring and managing change controls, procedures, test methods and deviations.
- Result authorization for microbiological samples to support batch release.
- GLIMS System updates.
- Assessing compendial and quality manual updates pertaining to the Microbiology Lab environmental control.
- Supporting lab stock management and financial control as required.
- Interpreting customer needs, assessing requirements, and identifying solutions to non-standard requests.
- Making decisions within guidelines and policies which impact microbiology projects.
- Ensuring highest safety standards.
- Performing other duties as assigned.
What skills you will need:
In order to excel in this role, you will more than likely have:
- Bachelor’s degree in Microbiology, Biology, Biotechnology, Pharmaceutical Science, or a related Life Sciences field.
- Minimum 3 years of hands-on experience in microbiology/QC, specifically in environmental monitoring and utilities monitoring, supporting site projects, trending, risk assessments, and data analysis.
- Ability to author procedures, change controls, deviations, reports, and work in line with regulatory/compendial requirements.
- Strong troubleshooting, decision-making, and ability to drive improvements such as lean lab initiatives and method optimization.
- Strong microbiology background and strong understanding of aseptic processing, environmental monitoring programs, and contamination control in sterile manufacturing.
- Experience in a GMP QC laboratory with knowledge of regulatory expectations.
- Familiarity with ALCOA() data integrity principles, electronic laboratory systems, and controlled documentation.
- Entry- to early-career level with growing technical competence; able to perform routine tasks with limited discretion.
- Experienced with review of EM/utilities data
- Experience with EM and utilities risk assessments
- Experience with qualification and requalification of cleanrooms and utility systems
- CAARE form experience assessment of cleanroom impacting area risk assessment and evaluations
The Carlow site broke ground in 2008 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 dont hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process.
Required Skills:
Adaptability, Adaptability, Analytical Instrumentation, Analytical Method Development, Data Integrity, Dissolution Testing, Driving Continuous Improvement, Environmental Controls, Environmental Monitoring, Environmental Monitoring Systems, GMP Compliance, Karl Fischer Titrations, Laboratory Documentation, Laboratory Safety, Life Science, Microbiological Analysis, Microbiological Test, Microbiology, Molecular Microbiology, Operations Support, Pharmaceutical Sciences, Project Management, Risk Assessments, Safety Standards, Teamwork {+ 2 more}
Preferred Skills:
Current Employees applyHERE
Current Contingent Workers applyHERE
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):
Job Posting End Date:
08/13/2026*A job posting is effective until 11:59:59PM on the dayBEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFORE the job posting end date.
Requisition ID: R408825
