Quality Control Specialist

Job Description

We have a great opportunity for a Quality Control Specialist to join our Carlow site. You will join a self-directed team and provide trouble shooting support. The quality control specialist will have the opportunity to be involved in and lead various exciting projects.

What you will do:

Bring energy knowledge innovation and leadership to carry out the following:

• Support new product introductions and provide quality expertise during product release.
• Generate review approve and expedite QC GMP documentation including Quality Notifications Laboratory Investigations CAPAs Effectiveness Checks SOPs SWIs change controls Annual Product Reviews Trend Reports Out of Process Control Limit (OOPCL) events and Compendial Assessments.
• Develop revise and roll out operational procedures and training materials.
• Lead and support batch release activities by completing timely investigations quality notifications OOPCL events and generating interim/summary reports.
• Raise and investigate CAPAs and quality notifications using standard problem-solving tools (FMEA Fishbone diagrams 5 Whys) and implement corrective actions via change management.
• Provide coaching mentoring and guidance to lab teams
• Act as a document system expert: review approve format and facilitate documentation workflows.
• Lead or support projects and promote teamwork open communication and a high-performing inclusive culture.
• Collaborate cross-functionally to ensure manufacturing testing and release processes comply with cGMP and regulatory standards.
• Support qualification/validation technical transfers and commercial operations with quality oversight.
• Perform laboratory testing and material inspections according to approved methods including analytical microbiological environmental monitoring and stability testing.
• Detect report investigate and close out out-of-specification (OOS) and out-of-trend (OOT) results.
• Manage and monitor Quality Management Systems generate performance and quality event reports.
• Provide quality support for supplier/material qualification validation risk management and quality agreements.

Lab operates on a two-shift cycle pattern (7am-3pm/3pm-11pm)

In order to excel in this role you will more than likely have:

• Bachelors degree or higher in Analytical Chemistry Biochemistry Biology or a related discipline preferred.
• 5 years experience in a pharmaceutical laboratory ideally in a similar role.
• Excellent troubleshooting analytical and problem-solving skills.
• Strong technical knowledge and scientific qualification relevant to the pharmaceutical environment.
• Strong experience with HPLC systems bioassay methods and associated software is desirable.
• Experience with cGMP GLP Quality Management Systems method validation and method transfer.
• Proficient in QC systems such as EN LIMS Trackwise and Microsoft Office.
• Knowledge of Irish European and international regulatory codes and standards.
• Effective verbal and written communication skills with strong influencing capability.
• Commitment to maintaining a safe compliant and quality-focused culture.

As a company we are committed to Inventing for Life in all that we do. We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the worlds most challenging healthcare needs.

We are proud to be a company that embraces the value of bringing diverse talented and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment.

So if you are ready to:

Invent solutions to meet unmet healthcare needs Impact the future by driving one of the worlds leading healthcare companies and inspire your team to reach their full potential and push the boundaries of science and technology please apply today.

Required Skills:

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

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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: