{"id":3778543,"url":"https://alion.io/job/merck-co-manager-quality-assurance-second-shift","title":"Manager, Quality Assurance Second Shift","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":97,"open_postings":192,"ghost_share":0.031,"stale_share":0.156,"repost_share":0.177,"time_to_fill_p50_days":16,"computed_at":"2026-11-10T06:52:35Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","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":["Durham, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":96200,"max":151400,"currency":"USD","period":"year","gross":null,"usd_annual":151400},"salary_estimate":null,"experience_years_min":2,"visa_sponsorship":true,"relocation_package":false,"has_equity":false,"technologies":[{"name":"GMP","optional":false},{"name":"Microsoft Excel","optional":true},{"name":"Veeva","optional":true}],"status":"live","first_seen_at":"2026-11-04T00:00:00Z","employer_posted_date":"2026-11-04","last_verified_at":"2026-11-10T03:50:29Z","board_verified":true,"closed_at":null,"days_open":6,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":6},"description":"Job Description\nOur Company has constructed a new manufacturing facility to significantly expand its production capacity. Global demand has outpaced our current maximum manufacturing capabilities. Once this new facility is fully operational, we will triple our current manufacturing capacity, which is expected to support the anticipated demand for the foreseeable future. This investment reaffirms our Company’s longstanding dedication to producing this medicine for the patients who need it. The facility will include end-to-end processing of drug substance, drug product, including biotech culture growth, harvest, lyophilization, product inspection, and quality control laboratories.\nThe Quality Assurance Manager will direct Shop Floor Quality Assurance (SFQA) B160 to support process and technology introduction, compliance improvements, and manufacturing readiness to initiate production of commercial product. The focus for the position includes all aspects of Shop Floor QA oversight supporting Second Shift (Evening Shift).\nResponsibilities\nReporting to the Quality Assurance Organization, will independently manage Shop Floor Quality Assurance team on second shift.\nLead a Shop Floor QA team to provide end-to-end QA support for Production Support & Media, Drug Substance and Drug Product throughout the project lifecycle.\nEnsure all aspects of the Shop Floor QA proceed in compliance with cGMP, regulations, and our Company’s Quality Management System focusing on batch record review, process/aseptic observations, critical site review, critical alarm management, environmental monitoring incursion/excursion response.\nWill support and prepare Set-up Activities for SFQA First Shift (Days).\nSupport Operations and the Technical Operations Deviation Management groups with event assignments, classifications, investigations, corrective and preventative actions, reviews and approvals through current Quality Systems (e.g., CLUE and SAP).\nSupport and maintain a \"Safety First\", \" Quality Always\" environment with participation in Site GEMBAs for Safety and Quality Compliance.\nEscalate and collaborate quality and compliance issues as needed through established site Tiers.\nLeads and Supports the Aseptic Observer Program (AOP) and Batch Record Review (BRR) workstreams for the SFQA Area.\nMakes decisions guided by policies and procedures that impact the team’s ability to meet performance objectives and metrics. Consults on an as-needed basis with next level manager on more complex decisions.\nActively sponsor and develop a culture that defines a High-Performing Organization including proactively providing developmental support, coaching and assistance to team members.\nSupport compliance to Durham Site policies and procedures that promote Permanent Inspection Readiness (PIR).\nConsults on an as-needed basis with next level manager on more complex decisions.\nMinimum Required Education and Experience:\nBachelor’s degree in chemical engineering, biochemical engineering, biological systems engineering, biology, biochemistry, chemistry or related life science or engineering discipline with five (5) years in the pharmaceutical industry or highly regulated industry. \nOR\nMaster’s degree in chemical engineering, biochemical engineering, biological systems engineering, biology, biochemistry, chemistry or related life science or engineering discipline with three (3) years in the pharmaceutical industry or highly regulated industry\nRequired Experience and Skills:\nMinimum two years in aseptic manufacturing or other clean room environment\nMinimum one year in people management or equivalent direct leadership experience.\nStrong contemporary knowledge of relevant current good manufacturing practices (cGMPs), regulations and current industry trends.\nEffective decision making, problem solving and communication. Ability to manage multiple priorities.\nDemonstrated ability to work in fast-paced, complex environments and escalate appropriately.\nPreferred Experience and Skills:\nGMP quality experience with media, biological drug substance and drug product.\nStrong Background in cGMP document review and approval.\nStrong background in cGMP compliance standards (QMS, EHS, and Site SOPs)\nIndependent, self-directed strong skill sets in planning / scheduling, and time management.\nExperience with Quality Risk Management.\nExperience with Deviation Management.\nExperience with Kneat, Veeva Vault, MEDS, SAP, Electronic Batch Records (MES), Trackwise and GLIMS.\nRCA (Root Cause Analysis) with problem-solving experience utilizing MPS / LSS tools, including demonstrated proficiency in MPS 8-Step Problem Solving.\nSoftware Proficiency: Microsoft Excel, Work, PowerPoint, Teams. #SWE2026 #EBRG #VetJobs \nRequired Skills:\nAnalytical Problem Solving, Analytical Thinking, cGMP Compliance, Decision Making, Detail-Oriented, Driving Continuous Improvement, Key Performance Indicators (KPI), People Leadership, Quality Auditing, Quality Control Systems, Quality Documentation, Quality Management Standards, Quality Management Systems (QMS), Root Cause Analysis (RCA), Supplier Quality ManagementPreferred 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 - North Carolina - Durham (Old Oxford)Where required by law, the compensation range for this role is provided below.\nThe salary range for the primary location of this role is:\n$96,200.00 - $151,400.00This 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:\nDomesticVISA Sponsorship:\nNoTravel Requirements:\n10%Flexible Work Arrangements:\nNot ApplicableShift:\n2nd - EveningValid Driving License:\nNoHazardous Material(s):\nN/AJob Posting End Date:\n11/11/2026*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. 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