{"id":1684165,"url":"https://alion.io/job/abzena-qa-operations-supervisor","title":"QA Operations Supervisor","company":{"id":2138905,"name":"Abzena","domain":"abzena.com","url":"https://alion.io/company/abzena","size_band":null,"is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Lever","truth_index":{"grade":"B","score":75,"open_postings":4,"ghost_share":0,"stale_share":1,"repost_share":0,"time_to_fill_p50_days":null,"computed_at":"2026-10-06T05:45:30Z"}},"role":"QA","role_family":"QA","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":["San Diego, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":100000,"max":120000,"currency":"USD","period":"year","gross":null,"usd_annual":120000},"salary_estimate":null,"experience_years_min":4,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-08-12T21:24:57Z","employer_posted_date":"2026-08-12","last_verified_at":"2026-10-07T01:24:59Z","board_verified":true,"closed_at":null,"days_open":55,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":55},"description":"The Quality Assurance Operations Supervisor is responsible for leading Quality oversight activities and fostering an empowered culture of quality across manufacturing processes supporting biologics production, including cell culture, fermentation, harvest, purification, and bulk drug substance. This role provides direct supervision of quality personnel, will be a primary point of contact for on-the-floor escalations, will support quality records and document review and approvals.\nThe supervisor serves as a key operational leader, managing shift resources, supporting technology transfer and process validation activities, and partnering with Manufacturing, Supply Chain, Facilities, and MSAT teams to achieve production objectives.\nResponsibilities\nLead hands-on QA collaboration and oversight to staff, ensuring compliance with good documentation practices (GDP), data integrity compliance, site inspection readiness SOPs, and relevant Good Regulated Practice (GxP) requirements.\nSupervise work on the floor during production and assess decisions to ensure compliance with manufacturing procedures and regulations when departures occur.\nLead batch record review on the floor at time of execution for buffer / media/ upstream and downstream manufacturing batch records.\nLead disposition of buffer/media solutions manufactured at Abzena.\nSupervise performance of regular area walkthroughs of the manufacturing, warehouse and Quality Control areas.\nAuthor/Approve minor and major manufacturing deviations and perform a thorough root cause to drive remediation efforts in the organization and process improvements.\nReview and approve manufacturing deviations (minor/major), risk assessments, CAPAs, change controls, and Standard Operating Procedures (SOPs).\nReview and approve master buffer / media / Process batch record and client batch records.\nSupport in client and internal audits as required.\nSupport other departments as required to fulfill business needs.\nComply with Abzena's policies and procedures.\nCommunicate effectively with clients, colleagues and staff.\nAdhere to quality standards set by regulations and Abzena policies, procedures, and mission.\nTeam Leadership & Development\nSupervise, coach, mentor, and develop quality assurance associates\nConduct performance evaluations and establish development plans for team members.\nFacilitate onboarding and qualification of new employees.\nPromote a culture of safety, teamwork, accountability, and continuous improvement.\nLead daily shift meetings and attend daily tier meetings as required.\nSafety & Operational Excellence\nChampion Environmental Health and Safety (EHS) compliance.\nEnsure safe handling of biological materials, chemicals, and manufacturing equipment.\nLead risk assessments and support implementation of corrective actions.\nDrive Lean Manufacturing and continuous improvement initiatives.\nMonitor and improve key performance indicators (KPIs) including safety, right-first-time execution, batch success rate, and schedule adherence.\nCross-Functional Collaboration\nPartner with Manufacturing, Quality Control, Validation, Facilities, Engineering, Supply Chain, and Program Management teams.\nSupport customer visits and client-facing manufacturing discussions as required.\nQualifications\nRequirements:\nBachelor’s degree in Life Sciences, or related scientific discipline.\n Minimum of 4 years of experience in biopharmaceutical manufacturing within a GMP-regulated environment. \nMinimum of 3 years of experience in a Quality Assurance related function\nMinimum of 2 years of leadership or supervisory experience.\nHands-on experience with biologics operations in either a Quality or Production role. \nQualifications (Preferred)\nExperience in CDMO manufacturing environments. \nLean Six Sigma certification or continuous improvement experience.\nKnowledge of monoclonal antibody and recombinant protein manufacturing processes.","description_format":"text","description_chars":3900,"description_truncated":false,"requirements":{"experience_years_min":4,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Biotechnology"],"lifecycle":[{"event":"open","at":"2026-10-02T10:02:46Z"}],"visa":[],"liveness":{"score":17,"band":"cold","label":"Long shot","p_open":1,"p_active":0.473,"p_room":0.35,"age_days":54,"expected_fill_days":18,"reasons":["conf:1","urgency","win:tail"],"computed_at":"2026-10-06T05:45:30Z"},"pay":{"stated_usd_annual":120000,"is_top_pay":true},"html_url":"https://alion.io/job/abzena-qa-operations-supervisor","json_url":"https://alion.io/job/abzena-qa-operations-supervisor.json","meta":{"generated_at":"2026-10-07T02:16:11Z","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","counted_by":"address","units_charged":1,"used_today":3781,"day_limit":5000,"remaining_today":1219,"minute_limit":60,"resets_at":"2026-10-08T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"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":2138905},"rest":"https://alion.io/mcp/rest/get_company?id=2138905"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fabzena-qa-operations-supervisor"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"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%2Fabzena-qa-operations-supervisor"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"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%2Fabzena-qa-operations-supervisor"},{"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/abzena-qa-operations-supervisor\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fabzena-qa-operations-supervisor"}]}