Spclst, Quality Control

Carlow
Permanent
Full-time

6 days ago

Job DescriptionA fantastic opportunity has arisen for a Spclst, Quality Control.The Specialist, Quality Control is responsible for supporting Quality Control operations and quality systems to ensure compliance with company Global Quality standards, regulatory requirements, and current Good Manufacturing Practices (cGMP). The role provides technical expertise in QC documentation, investigations, and continuous improvement to support robust product quality and reliable supply.There may be a shift element to this role so requires candidates to be flexible.Bring energy, knowledge, innovation to carry out the following:

Execute and support QC activities in alignment with company Global Policies, Procedures, and the Global Quality Management System.
Ensure compliance with applicable regulatory requirements and cGMP expectations across all assigned activities.
Demonstrate a strong culture of quality, data integrity, and inspection readiness.

Author, review, approve, and provide technical oversight for QC GMP documentation, including but not limited to:

Laboratory Investigations
Quality Notifications
CAPAs and Effectiveness Checks
SOPs, Standard Work Instructions (SWIs), and training documentation
Change Controls
Annual Product Reviews (APR)
Trend Reports
Out of Process Control Limit (OOPCL) events
Act as a subject matter expert for QC documentation systems, ensuring effective document lifecycle management, workflow efficiency, and timely approvals.
Facilitate and mentor others in the preparation of compliant, high‑quality documentation.
Support QC laboratory operations through generation, review, and management of GMP documentation associated with routine operations and atypical events.
Support batch disposition and release activities through timely completion of investigations, Quality Notifications, OOPCLs, and summary reports.
Support new product introductions (NPI), technology transfers, and lifecycle activities from a QC compliance and documentation perspective.

Lead and support deviation and investigation activities using structured root cause analysis tools (e.g. FMEA, Fishbone, 5‑Whys).
Initiate and manage CAPAs and Quality Notifications to resolution, ensuring sustainable corrective and preventive actions.
Drive continuous improvement by identifying trends, system gaps, and opportunities to strengthen QC processes.

Perform and/or support compendial assessments and analytical method validation activities, as required.
Maintain current knowledge of Irish, European, and international regulatory expectations relevant to Quality Control operations.

What skills you will need:In order to excel in this role, you will more than likely have:

Degree in Science or similar
Proven experience in cGMP Quality Control and quality systems within a regulated pharmaceutical or biopharmaceutical environment.
Strong technical writing capability, including reports, standards, and policies.
Demonstrated analytical thinking and structured problem‑solving skills.
Proficiency with Microsoft Office and quality‑related electronic systems.
Strong attention to detail and commitment to quality and compliance.
Effective prioritisation, time management, and ability to manage multiple activities concurrently.
Clear communicator with the ability to influence, collaborate, and operate effectively in cross‑functional teams.
Flexible, resilient, and results‑driven approach aligned with company values.

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 don't hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process.Required Skills: Manufacturing Compliance, Microbiological Analysis, Pharmaceutical Biology, Regulatory Compliance, Regulatory Requirements, Technology Transfer, Use of Laboratory EquipmentPreferred Skills:Current Employees applyCurrent Contingent Workers applySearch 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: RegularRelocation: No relocationVISA Sponsorship: NoTravel Requirements: 10%Flexible Work Arrangements: Not ApplicableShift: Not IndicatedValid Driving License: NoHazardous Material(s): NAJob Posting End Date: 04/23/2026*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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