{"id":4282102,"url":"https://alion.io/job/bio-techne-manager-quality-control","title":"Manager, Quality Control","company":{"id":7354,"name":"Bio-Techne","domain":"bio-techne.com","url":"https://alion.io/company/bio-techne","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"A","score":86,"open_postings":7,"ghost_share":0,"stale_share":0.571,"repost_share":0,"time_to_fill_p50_days":58,"computed_at":"2026-11-14T05:58:10Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"middle","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Devens, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":91700,"max":150800,"currency":"USD","period":"year","gross":null,"usd_annual":150800},"salary_estimate":null,"experience_years_min":3,"visa_sponsorship":true,"relocation_package":false,"has_equity":true,"technologies":[{"name":"CAPA","optional":false},{"name":"GMP","optional":false},{"name":"ISO 13485","optional":false}],"status":"live","first_seen_at":"2026-11-13T20:45:29Z","employer_posted_date":"2026-11-13","last_verified_at":"2026-11-14T21:36:29Z","board_verified":true,"closed_at":null,"days_open":1,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":1},"description":"By joining Bio-Techne, you’ll join a company with a powerful and positive purpose of enabling cutting-edge research in Life Sciences and Clinical Diagnostics. Bio-Techne, and all of its brands, provides tools for researchers to further treat and prevent disease worldwide.\nPay Range:\n$91,700.00 - $150,800.00Position Summary:\nThe position requires management of the day-to-day operations within the various Quality Control groups (including QC laboratory, Incoming QC). Procedures and processes developed and supported must adhere to FDA cGMP and ISO 13485 Medical Device Requirements. Principal testing types include: blood gas and electrolytes, glucose, co-oximetry, general chemistries, and coagulation.\nResponsibilities:\nManage and lead the team, including but not limited to ensuring adequate staffing levels, recruitment, training, development, appraisal, attendance, disciplinary issues, and quick, effective problem resolution that maximizes efficient productivity and delivers a high level of employee engagement. Oversee daily functions of each department and identify opportunities for improvement \n\nDrive training and development of team members and work closely with department Supervisors to ensure the completion of team and individual goals. Help supervisors organize and schedule workflow in each functional area (Incoming QC and QC lab) to ensure smooth operation.\nProvide direction and support to all QC-related functions.\n\nAlign with senior leadership initiatives and support corporate goals for the business. Maintain a regular ‘on-floor’ presence, regularly adopting GEMBA techniques. \nPositively engage with personnel to understand challenges and issues through continuous assessment and implement change where necessary. \nLead/participate in continuous improvement initiatives in line with the vision of the department and the business. \nMentor, motivate, and empower personnel within the team to implement change successfully. \nSupport senior leadership initiatives and specific site goals. \n\nPartner with Manufacturing, Quality Assurance, Supply Chain, and R&D to resolve product quality issues and support business objectives.\nEstablish and monitor quality control systems.Oversee program for the monitoring of temperature-controlled storage areas\nIdentify critical points in the manufacturing processes where quality checks can be added.\nDevelop inventory systems for critical lab supplies, reagents, and reference materials.\n\nParticipate in New Product Development supporting test methods for new product types.Develop appropriate sampling plans, test protocols, and quality standards for raw materials, work in process, and finished goods as required for new product development activities\nSupport new product launch activities, including pilot lots.\n\nCoordinate and oversee instrument acquisition and validation activitiesParticipate in budgetary review and capital expenditure process for new instrument requests.\nParticipate in test equipment validation planning, execution and implementation.\nSupport validation activities related to design changes or technology refresh.\n\nLead investigation and resolution of Out-of-Specification (OOS), Out-of-Trend (OOT), laboratory deviations, and invalid assay results. \nEnsure timely completion and effectiveness of laboratory investigations and associated CAPAs.\nEnsure QC operations maintain inspection readiness for FDA, ISO 13485, customer, notified body, and internal audits. \nLead responses to QC-related audit observations and regulatory findings.\nOversee stability testing programs including real-time, accelerated, and in-use stability studies. \nMonitor stability trends and support shelf-life assignments and extensions.\nFollow company policies and practices as outlined in the Handbook, SOPs and WIs and as well as follows guidelines regarding safety as outlined in the safety program and in accordance to the job functions in the department.\nDemonstrates flexibility to support business needs, including occasional extended work hours during investigations, audits, validations, new product launches, or critical business activities.\nWillingness to accept changes in work from day-to-day within reasonable and expected boundaries\nPerform other duties as assigned.\nQualifications:\nBachelor's degree in Chemistry, Biochemistry, Biology, Clinical Laboratory Science, or related discipline required. \n8+ years of laboratory, quality control, or analytical testing experience in a regulated medical device, IVD, biotechnology, or pharmaceutical environment. \nMinimum 3-5 years of people leadership experience required.\nDemonstrated experience with FDA QSR/QMSR, ISO 13485, and cGMP requirements. \nExperience with assay validation, method transfers, statistical analysis, and root cause investigations. \nExperience supporting FDA, ISO, customer, or notified body audits preferred.\nMinimum Physical Requirements:\nRemain seated in a normal position for extended periods of time up to 8 hours\nWalk, stand, and move about at various times in the workday\nReach up and out with hands and arms\nTalk and hear; verbally express information\nKeyboard, 10 keys for extended periods\nRepetitive motion; hands \nLift up to 25 pounds and carry at a distance of 10 feet\nWhy Join Bio-Techne:\nWe offer competitive insurance benefits starting on day one: medical, dental, vision, life, short-term disability, long-term disability, pet, and legal and ID shield.\n\nWe invest in our employees’ financial futures through 401k plans, an employee stock purchase plan (ESPP), Health Saving Account (HSA), Flexible Spending Account (FSA), and Dependent Care FSA.\n\nWe empower our employees develop their careers through mentorship, promotional opportunities, training and development, tuition reimbursement, internship programs, and more.\n\nWe offer employee resource groups, volunteer paid time off, employee events, and charity drives to build a culture of caring and belonging.\n\nWe offer an accrued leave policy with paid holidays, paid time off, and paid parental leave.\n\nWe foster a culture of empowerment and innovation, where employees feel valued and encouraged to bring their new ideas to the table.\n\nBio-Techne is an E-Verify Employer in the United States.\nAll qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.\nTo protect the interests of all, Bio-Techne will not accept unsolicited resumes from any source other than a candidate application. Any unsolicited resumes sent to Bio-Techne will be considered Bio-Techne property.\nThis position requires work authorization that does not now or in the future require sponsorship of a visa for employment authorization in the United States (e.g., H1-B visa, F-1 visa (OPT), TN visa or any other non-immigrant work status). If you require a reasonable accommodation to complete an application, participate in an interview, or take part in any other stage of the recruitment process, please  assistance.","description_format":"text","description_chars":7087,"description_truncated":false,"requirements":{"experience_years_min":3,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["401k plan","Parental leave"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Diagnostic Tests & IVD","Molecular Diagnostics","Precision Medicine","Laboratory Equipment"],"lifecycle":[{"event":"open","at":"2026-11-13T20:45:29Z"}],"visa":[],"liveness":{"score":86,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.86,"p_room":1,"age_days":0,"expected_fill_days":58,"reasons":["conf:2","win:early"],"computed_at":"2026-11-14T05:58:10Z"},"pay":{"stated_usd_annual":150800,"is_top_pay":true},"html_url":"https://alion.io/job/bio-techne-manager-quality-control","json_url":"https://alion.io/job/bio-techne-manager-quality-control.json","meta":{"generated_at":"2026-11-14T23:33:48Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":31545,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-15T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.1,"usd":0.01,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":7354},"rest":"https://alion.io/mcp/rest/get_company?id=7354"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fbio-techne-manager-quality-control"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"free","price":{"credits":0,"usd":0},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Fbio-techne-manager-quality-control"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.1,"usd":0.01},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Fbio-techne-manager-quality-control"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/bio-techne-manager-quality-control\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fbio-techne-manager-quality-control"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":4282102}},{"tool":"search_jobs","arguments":{"company":"bio-techne.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":4282102},"note":"people open to offers who fit this vacancy"}],"note":"The same data through MCP tools: https://alion.io/mcp/open needs no sign-in (compact searches, postings, people); https://alion.io/mcp with an Alion account has everything. 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