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Specialist- Quality
2 weeks ago
Job Description
Roles and Responsibilities:
- Operate as part of the QC team according to Company safety policies and cGMP to drive compliance with our company's Global policies, procedures, guidelines and regulatory requirements in the performance of all applicable job functions.
- Complete all documentation in compliance with cGMP and GxP standards.
- Perform receipt and release of all materials ensuring QC Right First Time and turnaround time KPIs are achieved.
- Review of all vendor and external laboratory documentation associated with receipt and release of materials to ensure compliance with internal specifications and Pharmacopeia.
- Maintain clear, accurate records associated with all day to day activities.
- Demonstrate proficiency in job related computer applications e.g., SAP, LIM's
- Demonstrate ability to navigate, understand and comply to company test specifications and Pharmacopeia.
- Facilitate and drive effective communication to ensure success. Liaise effectively with external groups to ensure progress of material receipt and release. Collaborating with others by sharing your skill set and expertise.
- Support and participation in Internal Investigations Ensure that all Quality Systems within the department are adhered to on a daily basis.
- Problem solving to get to root cause of issues.
- Provide support with audit/inspection requirements to ensure department compliance/readiness.
- Participate in internal and external audits and inspections.
Qualification and Experience:
- Minimum 6 years' experience in the Pharmaceutical, Biopharmaceuticals industry or a similar operating environment which includes experience in a Quality function.
- Degree in Science, Engineering or similar
- Good communication, interpersonal skills and ability to work across teams.
- Proven organizational skills and excellent attention to detail
- Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices
- Proficiency in Microsoft Office and job-related computer applications required e.g., SAP, LIM's
- Demonstrated ability to work independently and fully realize improvement initiatives with a moderate level of guidance.
- Demonstrated ability to drive the completion of tasks.
- Proven decision-making capability with accountability and responsibility.
- Demonstrated ability to solve problems.
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:
Regular
Relocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Hybrid
Shift:
Valid Driving License:
Hazardous Material(s):
Required Skills:
Adaptability, Adaptability, Aseptic Manufacturing, Audit Management, Biopharmaceutical Industry, Biopharmaceuticals, cGMP Compliance, Communication Strategy Development, Compliance Assurance, Data Analysis, Decision Making, Documentation Review, Documentations, FDA Regulations, Internal Auditing, Internal Inspection, Internal Investigations, Interpersonal Relationships, IS Audit, Laboratory Operations, Laboratory Quality Control, Management Process, Microsoft Office, Problem Solving Therapy, Process Improvements {+ 5 more}
Preferred Skills:
Job Posting End Date:
10/31/2025
- 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.
Requisition ID:R366488
