Job Purpose
Generating and expediting review and approval processes for IPT GMP documentation including Quality Notifications, CAPA close out records, IPT Standard Operating Procedures and Standard Work Instructions and change controls.
Responsibilities
- Support manufacturing activities through documentation generation, equipment and process investigations associated with non-GMP activities and completion of quality notifications.
- Provide input to the MES development process team on technical aspects of MES functionality and serve as MES SME within IPT
- Be a document system expert; this will include document review, approval and document system work flow expedition. Format, write, deliver and review necessary documentation in line with the standard approval process
- Support operation activities through documentation generation, filing, tracking, auditing and efficient maintenance of all associated databases
- Support Batch release through timely Quality Notification completion, Interim/summary report generation; meeting batch release requirements.
- Raise CAPA's and conduct investigations. Raise and investigate quality notifications using standard tools and methods, to resolve system issues e.g. FMEA, Fishbone diagrams, 5 why’s etc.; implement subsequent corrective action through the change management system.
- Complete Customer complaint investigations and Change Controls
- Work collaboratively to drive a safe and compliant culture in Carlow.
- Currently pursing Bachelor’s Degree or higher preferred; ideally in a Science, Engineering or other Technical discipline
- Proficiency in Microsoft Office and job related computer applications required
- Excellent communication, presentation and interpersonal skills, to interface effectively with levels of colleagues and with external customers in a team orientated manner
- Excellent attention to detail
Required Skills
Analytical Problem Solving, Clinical Research, Data Analytics, Database Management, Data Entry, Data Visualization, Document Management, Health Economics, Office Applications, Process Improvements, Project Management, Reporting and Analysis, Technical Support, Technical Training, Workload Prioritization
Preferred Skills
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
Intern/Co-op (Fixed Term)
Relocation
No relocation
VISA Sponsorship
No
Travel Requirements
No Travel Required
Flexible Work Arrangements
Hybrid
Shift
Not Indicated
Valid Driving License
No
Hazardous Material(s)
N/A
Job Posting End Date
09/16/2026
- 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.
