{"id":3761041,"url":"https://alion.io/job/merck-co-specialist-operational-quality-control","title":"Specialist, Operational Quality Control","company":{"id":3768,"name":"Merck & Co.","domain":"msd.com","url":"https://alion.io/company/msd","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"A","score":98,"open_postings":191,"ghost_share":0.026,"stale_share":0.105,"repost_share":0.173,"time_to_fill_p50_days":16,"computed_at":"2026-11-06T05:58:05Z"}},"role":"MedTech","role_family":"MedTech","seniority":"junior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["West Point, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":87300,"max":137400,"currency":"USD","period":"year","gross":null,"usd_annual":137400},"salary_estimate":null,"experience_years_min":1,"visa_sponsorship":true,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"GLP","optional":false},{"name":"GMP","optional":false}],"status":"live","first_seen_at":"2026-11-04T18:32:36Z","employer_posted_date":"2026-11-04","last_verified_at":"2026-11-06T10:06:53Z","board_verified":true,"closed_at":null,"days_open":1,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":1},"description":"Job Description\nPosition Overview\nThe Quality Specialist supports the Micro Sterility Assurance Laboratory by providing quality and compliance oversight for sterility assurance testing activities. This role ensures laboratory operations are conducted in accordance with GMP requirements, approved SOPs, and company quality standards. The incumbent will support routine and non-routine Micro Sterility Assurance testing activities, review documentation for accuracy and completeness, and partner with laboratory and quality teams to drive continuous improvement. In addition, this position will support process improvement initiatives through MPS, helping identify opportunities to improve efficiency, compliance, and operational performance.\nThe Quality Specialist is expected to maintain a strong understanding of GMP, SOPs, deviations, and other quality system requirements, while ensuring work is completed accurately, consistently, and in compliance with regulatory expectations.\nEssential Functions\nProvide quality support to Micro Sterility Assurance laboratory operations and testing activities.\nSupport Micro sterility assurance testing processes in accordance with GMP, SOPs, and applicable quality standards.\nReview laboratory documentation, records, and data for accuracy, completeness, and compliance.\nAssist in deviation investigation, documentation, and follow-up actions.\nSupport quality system activities including change control, documentation review, and CAPA where applicable.\nPartner with laboratory staff and quality representatives to ensure compliance and timely resolution of quality issues.\nContribute to process improvement initiatives using MPS to improve laboratory efficiency, standardization, and compliance.\nParticipate in root cause analysis and problem-solving activities related to laboratory quality events.\nEnsure adherence to data integrity, documentation practices, and good laboratory practices.\nSupport internal audits, inspection readiness, and other quality-related assessments as needed.\nMonitor trends, identify recurring issues, and recommend corrective and preventive actions.\nAssist with the implementation and maintenance of quality metrics and continuous improvement plans.\nParticipate in daily tier meetings to review priorities, escalate issues, track action items, and support timely resolution of operational and quality concerns.\nQualifications\nBachelor’s degree in Microbiology, Biology, Biochemistry, Chemistry, or related scientific discipline preferred.\n1+ years of experience in a GMP-regulated environment, preferably in a microbiology or sterility assurance setting.\nWorking knowledge of SOPs, deviations, investigations, and quality systems.\nExperience supporting laboratory testing and documentation review.\nFamiliarity with continuous improvement tools and MPS principles preferred.\nStrong attention to detail, organizational skills, and analytical thinking.\nEffective communication and collaboration skills.\nAbility to work independently and within cross-functional teams.\nPreferred Skills\nExperience in sterility assurance, microbiological testing, or quality assurance laboratory support.\nUnderstanding of CAPA, change control, and audit readiness processes.\nAbility to support process improvement and standardization efforts.\nStrong problem-solving mindset and commitment to compliance.\nThe role is part of a 7-day operation and may require flexibility to support business and laboratory needs.\nRequired Skills:\nAdaptability, Analytical Instrumentation, Analytical Method Development, CAPA Management, Continuous Improvement Techniques, Deviation Management, Deviation Reporting, Driving Continuous Improvement, GMP Compliance, Good Lab Practices, Inspection Readiness, Laboratory Analysis, Laboratory Documentation, Laboratory Quality Control, Laboratory Safety, Microbiological Analysis, Quality Assurance (QA), Quality Improvement, Quality Metrics, Sterility Assurance, Teamwork, Technical Writing, Trend Monitoring, Troubleshooting, Use of Laboratory EquipmentPreferred Skills:\nCurrent Employees apply HERE\nCurrent Contingent Workers apply HERE\nUS and Puerto Rico Residents Only:\nOur company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.\nAs an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. Asa federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:\nEEOC Know Your Rights\nEEOC GINA Supplement\nWe are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.\nLearn more about your rights, including under California, Colorado and other US State Acts\nThe primary location for this posting is:\nUSA - Pennsylvania - West PointWhere required by law, the compensation range for this role is provided below.\nThe salary range for the primary location of this role is:\n$87,300.00 - $137,400.00This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.\nWe offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.\nAdditional location(s): Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location.\nAdditional location(s) Compensation Information:\nSan Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance\nLos 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\nSearch Firm Representatives Please Read Carefully\nMerck & 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.\nEmployee Status:\nRegularRelocation:\nNo relocationVISA Sponsorship:\nNoTravel Requirements:\nNo Travel RequiredFlexible Work Arrangements:\nNot ApplicableShift:\n1st - DayValid Driving License:\nNoHazardous Material(s):\nYesJob Posting End Date:\n11/12/2026*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. 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