**Job Description** The Senior Quality Specialist, with guidance from the Integrated Product Team Quality Operations Leader or E2E Quality Operations Leader, ensures product/process quality through the review of GMP documents and oversight of GMP facilities and processes, enabling reliable supply of quality product and permanent inspection readiness. The Senior Quality Specialist ensures all documentation (e.g. Deviations, Change Requests, Instrument/Operational/Performance Qualifications, Validation) is approved, valid, and complies with both regulatory and internal for our Company requirements. The position may have an opportunity to perform people management, with management of activities and team members involving product quality complaint investigations. **Primary Activities include, but are not limited to:** + Leads and/or represents Quality on assigned project teams. + Executes and continuously improves processes and procedures related to material control, shop floor compliance, document review, deviation management, and change control within established policies and guidelines. + Supports company, site, and departmental operational excellence initiatives. + Maintains a working knowledge of regulatory guidance and trends, and our Company Manufacturing policies, guidelines and procedures. + Provides guidance to operations and/or laboratory operations on quality issues; utilizes strong problem solving and analytical skills to develop hypotheses and countermeasures for deviation response and continuous improvement. + Manages aspects of the material control as it relates to control of material for deviations, risk processing and change control. + Performs review and approval for investigations (complaints), deviations, Corrective Action and Preventive Action, Quality Compliance Tracking System commitments, standard operating procedures (SOPs), change requests, risks, Installation Qualification /Quality Operations/Process Qualifications, validation, Master Batch Records, etc + Performs Good Manufacturing Practice walkthrough inspections to ensure compliance with Good Manufacturing Practice and regulatory requirements and maintain permanent inspection readiness. + Participate as a member of the E2E Quality leadership team; support tier meetings and prepare / present routine project updates to IPT and/or E2E leadership. + Performs duties of the Quality IPT lead in his/her/their absence. **Education Minimum Requirement:** + B.S. degree in appropriate scientific/engineering field **Required Experience and Skills:** + Minimum of 5-years experience in a GMP manufacturing or laboratory facility, including but not limited to Quality Control, Quality Assurance, Technology, or Operations + Demonstrated analytical, problem-solving and communication (oral/written) skills + Effectiveness and creativity in approaching and solving technical problems + Experience in Change Control and Deviation Management + Attention to detail, flexibility and an awareness of production and quality control problems. + Strong understanding of regulatory requirements and current Good Manufacturing Practices (cGMPs) **Preferred Experience and Skills:** + Regulatory inspection experience (e.g. tours, topic presentation, facilitation) + Sterile/aseptic manufacturing experience, including aseptic gowning. Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld) Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld) **US and Puerto Rico Residents Only:** Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088\_EEOC\_KnowYourRights\_10\_20.pdf) EEOC GINA Supplement​ Pay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp\_%20English\_formattedESQA508c.pdf) We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts (https://www.msdprivacy.com/us/en/CCPA-notice/) **U.S. Hybrid Work Model** Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”. **San Francisco Residents Only:** We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance **Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance **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:** No relocation **VISA Sponsorship:** No **Travel Requirements:** No Travel Required **Flexible Work Arrangements:** Hybrid **Shift:** 1st - Day **Valid Driving License:** No **Hazardous Material(s):** n/a **Job Posting End Date:** 02/17/2025 ***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:** R331283