**Job Description** The Lyo Quality Operations group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe. The Senior Specialist, Quality Operations, with guidance from the Integrated Process Team Quality Operations Leader, ensures product/process quality through the review of Good Manufacturing Practice documents, facilities and processes and performs activities to ensure the reliable release of quality products to the marketplace. This role is responsible for ensuring adherence to Divisional, Company and Site policy, procedures and guidelines. This position requires strong quality, scientific, and communication skills. Strong collaboration and decision making are key attributes. Primary activities include: **Primary Activities:** + Acts as a Quality Operations representative for the Lyo IPT. As such, this individual must have sound knowledge of a wide variety of process, analytical, instrument and automation disciplines associated with operations. This individual is accountable for the shared operations, quality and technology objectives for their area within the Integrated Process Team, including deviation and discard reduction, schedule adherence, cycle time reductions and right first time. Coordinates and executes all Quality Operations activities to ensure production plans are met, utilizing the tier process. Supports project work in the building. + Manages aspects of the material control and/or release process as it relates to control of material for deviations, risk processing and change control. + Performs review and approval for investigations, Corrective Action and Preventive Action, Quality Compliance Tracking System commitments, 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. + Actively participates in site inspections/audits by facilitating discussions with inspectors/auditors, fulfilling requests for information and presenting to inspectors on required topics as Quality representative for the Integrated Process Team. Supports the preparation of regulatory filings. + Responsible for the review and release of filled product for downstream packaging for both domestic and international markets. + Oversees preparation and submission of protocols for Center for Biologics Evaluation and Research and international markets. Prepares to support regulatory filings. + Write, review, approve Standard Operating Procedures and other instructional documents for shop floor. + Provides training to incoming personnel and ensures compliance with departmental procedures. **Education Minimum Requirement:** + Bachelor's degree in a science, engineering, or related areas of study. **Required Experience and Skills:** + At least 5 years of experience in a pharmaceutical, biotech, or related industry. + Strong verbal and written communication skills. + Strong understanding of Good Manufacturing Practice and regulatory requirements (domestic and international). **Preferred Experience and Skills:** + Proficiency in project planning and execution. + Aseptic/Sterile processing experience preferred. + Effectiveness and creativity in approaching and solving technical problems. + Attention to detail, flexibility and an awareness of production and attendant quality control problems. + Demonstrated leadership expertise working with cross-functional teams. 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:** 02/19/2025 ***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:** R335201