Job Description

Specialist Quality:Principal Accountabilities:Bring energy, knowledge, innovation and leadership to carry out the following:

• Complete all documentation in compliance with cGMP and GxP standards.
• Support review of data within the required turnaround time, including follow up and escalations as required supporting team KPIs
• Prepare reports, complete review and assign comments as applicable
• Operate with proficiency in job related computer applications e.g., GLIMs, Microsoft Office
• Demonstrate ability to navigate, understand and comply to company test specifications and Pharmacopeia.
• Maintain clear, accurate records associated with all day to day activities.
• Facilitate and drive effective communication to ensure success. Liaise effectively with external groups to ensure progress of sample data review. 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.
• Ensure training is current for all job functions performed
• 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.

Qualifications, Skills & Experience Required

• \xe2\x80\x983 - 6 years\xe2\x80\x99 experience in the Pharmaceutical, Biopharmaceuticals industry.
• Degree in Microbiology
• Good communication, interpersonal skills and ability to work across teams.
• Proven organizational skills and excellent attention to detail
• Knowledge of regulatory/code requirements to EU and US pharmacopoeia
• Proficiency in English, being able to speak, read and write with minimal difficulty.
• Proficiency in Microsoft Office and job-related computer applications required e.g., SAP, GLIM\xe2\x80\x99s
• 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 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:VISA Sponsorship:Travel Requirements:Flexible Work Arrangements: HybridShift:Valid Driving License:Hazardous Material(s):

MSD