**Job Description** **Job Description** The Analytical Research & Development (AR&D) Stability Operations and Compliance department of our Company Research Laboratories Division is seeking applicants for a Senior Specialist position in the GxP compliance and documentation team to support the global AR&D organization. The position will be based at the West Point, Pennsylvania research facility. The Compliance Senior Specialist will work as part of the integrated Stability Operations and Compliance team and be pivotal in driving a culture of quality and operational excellence and enabling harmonization across the global AR&D network. This role is responsible for management and oversight of Good Manufacturing Practices (GMP) documentation, training, and standard operating procedures (SOPs) for global AR&D in addition to supporting the harmonization of AR&D procedures. The role will also focus on managing audit and inspection activities for AR&D groups at the West Point site including ensuring inspection readiness, working with the labs prior to audits/inspections for preparation efforts, supporting lab staff during audits/inspections, and managing observation responses and CAPAs. Experience supporting laboratory audits and inspections is a preferred skill. The qualified candidate must possess effective leadership skills to enable the identification and implementation of innovative strategies for improvement to support the development pipeline across modalities – biologics, small molecules, and vaccines. The successful candidate must be able to function independently and be able to collaborate in a fast-paced, integrated, multidisciplinary team environment.  We are looking for a team player with a passion for GMP compliance, strong organizational and project management skills, effective multi-tasking ability, and effective communication skills, both written and oral. Applicants must demonstrate a background of delivering innovative solutions to complex problems with a global mindset to drive cross-functional collaboration. **Education Minimum Requirements** + B.S. with 5+ years of post-degree relevant industry experience **Required Experience and Skills** + Bachelor’s degree, or higher, in analytical chemistry or related field + Minimum 5 years of experience in pharmaceutical or related industry supporting analytical laboratory testing or as quality assurance for laboratory areas. + An effective collaborator with the ability to work both independently and in a cross-functional team setting to deliver on complex objectives. + Demonstrated ability for taking initiative and innovative problem solving + Desire and ability to learn new concepts outside of core expertise and training + Excellent oral and written communication skills, demonstrated creativity, and effective interpersonal skills. + Experience working within a GMP environment. + Thorough understanding of GMP policies and procedures, knowledge of regulatory standards and proven experience working with Quality systems + Ability to work independently and within a cross-functional team to deliver complex objectives under aggressive timelines in a rapidly changing environment. **Preferred Experience and Skills** While not required, experience in one or more of the following areas is beneficial. + Demonstrated commitment to diversity and inclusion. + Experience leading a team for a common goal. + Experience authoring SOPs for GMP analytical laboratories. + Experience supporting GMP documentation and training within the pharmaceutical industry. + Experience supporting internal audits and external inspections for analytical laboratories. **Tag:** \#AR&D \#eligibleforERP 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:** Domestic **VISA Sponsorship:** Yes **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:** 03/4/2025 ***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:** R335270