Assoc. Spclst, Qual. Sys. & Compliance (WDA)

<p style="text-align:left">Job Description</p><p style="text-align:inherit"></p><p><b>Associate Specialist, Quality Systems &amp; Compliance (WDA) -2 years contract</b></p><p> </p><p>The position of Associate Specialist in Quality Management Systems (QMS) provides oversight on Quality Management System on site. The role will ensure and maintain high standards of quality and compliance within our organization.</p><p> </p><p>In this role, you will be responsible for all or subset of the key responsibilities below:</p><ul><li><p><span style="font-size:inherit">Manage overall QMS implementation in alignment with global.</span></p></li><li><p><span style="font-size:inherit">Develop Annual Schedule for QMS System health check and manage process/ platform to ensure adherence to schedule.</span></p></li><li><p><span style="font-size:inherit">Work with Site SMEs to prepare and ensure on time collation of site management review deck but not limited to site/quality metrics for reporting to site and corporate</span><br /><span style="font-size:inherit">management.</span></p></li><li><p><span style="font-size:inherit">Act as Site Quality Risk Management (QRM) Champion and manages Site Quality Risk Management Committee (SQRMC).</span></p></li><li><p><span style="font-size:inherit">Manage and perform the annual mock recall challenge for the Singapore Site.</span></p></li><li><p><span style="font-size:inherit">Perform quality review and approval of QMS gap assessment.</span></p></li><li><p><span style="font-size:inherit">Proactively identify and drive improvements in consultation with manager &amp; stakeholders.</span></p></li><li><p><span style="font-size:inherit">Act on escalations/feedback from stakeholders and work with cross functional teams to resolve the issues.</span></p></li></ul><p> </p><p>Qualifications &amp; Experience</p><ul><li><p><span style="font-size:inherit">Bachelor’s degree in Science/ Life Science, Pharmaceutical Science, Engineering or proven relevant experience.</span></p></li><li><p><span style="font-size:inherit">Minimum 2-4 years of applied professional work experience in quality operations/quality management system.</span></p></li><li><p><span style="font-size:inherit">Good knowledge and understanding of GMP and application of pharmaceutical regulatory requirements.</span></p></li></ul><p></p><p><b>Required Skills: </b></p>Accountability, Accountability, Audits Compliance, Biopharmaceutical Industry, Biopharmaceutics, cGMP Compliance, Consulting, Corrective Action Management, GMP Compliance, GMP Guidelines, IS Audit, Life Science, Manufacturing Audits, Manufacturing Compliance, Pharmaceutical Quality Assurance, Pharmaceutical Sciences, Pharmacy Regulation, Quality Control Management, Quality Improvement Programs, Quality Management, Quality Management System Improvement, Quality Process Development, Quality Standards, Regulatory Compliance, Regulatory Requirements {+ 3 more}<p></p><p><b>Preferred Skills: </b></p><p style="text-align:inherit"></p><p style="text-align:left">Current Employees apply <a target="_blank" href="https://wd5.myworkday.com/msd/d/task/1422$6687.htmld">HERE</a></p><p style="text-align:inherit"></p><p style="text-align:left">Current Contingent Workers apply <a target="_blank" href="https://wd5.myworkday.com/msd/d/task/1422$4020.htmld">HERE</a></p><p style="text-align:inherit"></p><p style="text-align:left"><b>Search Firm Representatives Please Read Carefully </b><br />Merck &amp; Co., Inc., Rahway, NJ, USA, also known as Merck Sharp &amp; 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. </p><p style="text-align:inherit"></p><p style="text-align:left"><b>Employee Status: </b></p>Intern/Co-op (Fixed Term)<p style="text-align:inherit"></p><p style="text-align:left"><b>Relocation:</b></p><p style="text-align:inherit"></p><p style="text-align:left"><b>VISA Sponsorship:</b></p><p style="text-align:inherit"></p><p style="text-align:left"><b><span>Travel Requirements:</span></b></p><p style="text-align:inherit"></p><p style="text-align:left"><b>Flexible Work Arrangements:</b></p>Not Applicable<p style="text-align:inherit"></p><p style="text-align:left"><b>Shift:</b></p><p style="text-align:inherit"></p><p style="text-align:left"><b>Valid Driving License:</b></p><p style="text-align:inherit"></p><p style="text-align:left"><b>Hazardous Material(s):</b></p><p style="text-align:inherit"></p><p style="text-align:left"><b>Job Posting End Date:</b></p>03/17/2026<p style="text-align:left"><b><span>*A job posting is effective until 11:59:59PM on the day <u>BEFORE</u> the listed job posting end date. Please ensure you apply to a job posting no later than the day <u>BEFORE</u> the job posting end date. </span></b></p>