{"id":3705961,"url":"https://alion.io/job/csbio-manager-gmp-quality-assurance","title":"Manager, GMP Quality Assurance","company":{"id":675342,"name":"CSBio","domain":"csbio.com","url":"https://alion.io/company/csbio","size_band":null,"is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workable","truth_index":null},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":null,"employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Milpitas, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":null,"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"GMP","optional":false}],"status":"live","first_seen_at":"2026-11-03T21:06:27Z","employer_posted_date":"2026-11-03","last_verified_at":"2026-11-12T05:59:57Z","board_verified":true,"closed_at":null,"days_open":8,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":8},"description":"CSBio is a peptide contract manufacturing founded in 1993. CSBio initial products were a complete line of automated synthesizers for manufacturing and process development, with a focus on cGMP production. In 1994, CSBio opened a custom peptide facility and began producing high quality compounds for research organizations and pharmaceutical companies worldwide. In 2004, CSBio opened a peptide production facility in Menlo Park, CA and in 2014, CSBio expanded production capability through the addition of a new, state of the art building dedicated to cGMP peptide production. In 2017, CSBio passed a FDA inspection and were recommended to be approved for commercial drug substance manufacturing. In 2023, additional cGMP clinical production capacity was added in Milpitas, CA.\nCSBiois seeking a hands-on Quality Assurance Manager to supervise daily QA activities supporting peptide manufacturing, laboratory operations, materials, documentation, and cGMP compliance. This person will manage QA staff and directly support document review, deviations, CAPAs, change controls, training, batch-record review, audits, and inspection readiness. Core duties and responsibilities include the following:\nJob Duties:\nSupervise daily QA work, assign priorities, review completion, train staff, and provide practical guidance on cGMP documentation and quality-system requirements.\nReview executed batch records, laboratory records, equipment and cleaning records, logbooks, labels, and supporting documentation for completeness and compliance.\nManage or support deviations, investigations, CAPAs, change controls, nonconformances, complaints, and effectiveness checks; ensure actions are documented and completed on time.\nCoordinate document control, SOP issuance, periodic review, archival, forms, templates, and controlled-copy practices.\nSupport employee training assignments, completion tracking, qualification records, and documentation of GMP readiness.\nPartner with Manufacturing, QC, Materials, Facilities, Validation, Regulatory, and management to resolve quality issues and prevent avoidable delays.\nProvide QA review and approval of validation plans, risk assessments, protocols, reports, and qualification documentation for facilities, utilities, equipment, processes, cleaning, analytical methods, and software systems.\nWork with system owners to maintain a practical validation assessment plan and address gaps in current or legacy validation documentation using documented risk-based decisions.\nSupport supplier qualification, material-status decisions, quality agreements, vendor documentation, and supplier corrective actions as assigned.\nManage or support customer-complaint investigations and approved recall or product-withdrawal procedures, including documentation, reconciliation, and authorized notifications.\nConduct or coordinate internal audits, floor observations, documentation reviews, and follow-up of findings.\nPrepare QA records and subject-matter experts for customer audits and regulatory inspections; track requests, responses, observations, and commitments.\nMonitor practical QA metrics such as overdue investigations, CAPAs, change controls, document reviews, training, batch-record review, and recurring documentation errors.\nEscalate product-quality, patient-safety, data-integrity, compliance, and release risks promptly to authorized Quality leadership.\nImprove QA workflows, templates, training, and quality-system usability without transferring QC laboratory or Manufacturing ownership into QA.\nRequirements\nBachelor’s degree in life sciences, chemistry, engineering, pharmacy, or a related field, or equivalent relevant experience.\n5+ years of Quality Assurance or closely related cGMP experience in pharmaceutical, biotechnology, peptide, API, sterile, medical-device, or other regulated manufacturing.\n2+ years of supervisory, lead, or functional-management experience, including work assignment, training, review, and employee development.\nHands-on experience with deviations, CAPAs, change controls, document control, training, batch-record review, audits, and inspection readiness.\nWorking knowledge of cGMP documentation, data integrity, traceability, quality risk, and cross-functional escalation.\nWorking knowledge of applicable FDA and ICH expectations and risk-based validation practices.\nStrong judgment, written communication, investigation, organization, and follow-through skills.\nBenefits\nMedical, dental, and vision insurance (Kaiser HMO or BlueShield PPO. Employer pays 85% for Employee and 50% for Employee’s family; Dental: Aetna Dental, Delta Dental, Guardian Dental, MetLife Dental. Vision: VSP and Aetna EyeMed)\nBasic life ($20,000 paid by company) and supplemental life insurance (optional supplemental).\nDisability insurance 50% standard employer paid.\n401k 10% 1:1 match\nPTO policy. 10 days PTO\nCompanywide paid holiday during: Week of July 4, Thanksgiving (2 days), Week of December 25\nCarpool, clean air vehicle, and cell phone reimbursement\nEmployee rewards and recognition program\nCompany organized social events\nQuarterly sponsored team building activities","description_format":"text","description_chars":5120,"description_truncated":false,"requirements":{"experience_years_min":null,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["401k plan","Life insurance","Vision insurance"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Synthetic Biology","Laboratory Equipment"],"lifecycle":[{"event":"open","at":"2026-11-03T21:06:27Z"}],"visa":[{"country":"US","licensed_sponsor":true,"adverts_offering_sponsorship_24m":0,"sanctioned_now":false,"evidence":"Filed H-1B visas in the last two years","filings_12m":0,"filings_prev_12m":1,"green_card_filings_12m":0,"median_offered_wage_usd":null,"route":null,"cap_exempt":false,"checked_at":"2026-11-11T07:38:50+00:00","sources":["US Department of Labor: LCA disclosure data (H-1B, H-1B1, E-3)"],"filings_for_role_12m":0}],"liveness":{"score":79,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.831,"p_room":0.945,"age_days":7,"expected_fill_days":13,"reasons":["conf:0","win:mid"],"computed_at":"2026-11-11T05:49:22Z"},"pay":null,"html_url":"https://alion.io/job/csbio-manager-gmp-quality-assurance","json_url":"https://alion.io/job/csbio-manager-gmp-quality-assurance.json","meta":{"generated_at":"2026-11-12T06:26:01Z","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":12765,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-13T00:00:00Z"}},"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":675342},"rest":"https://alion.io/mcp/rest/get_company?id=675342"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fcsbio-manager-gmp-quality-assurance"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":2,"usd":0.2},"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%2Fcsbio-manager-gmp-quality-assurance"},{"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%2Fcsbio-manager-gmp-quality-assurance"},{"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/csbio-manager-gmp-quality-assurance\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fcsbio-manager-gmp-quality-assurance"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3705961}},{"tool":"search_jobs","arguments":{"company":"csbio.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3705961},"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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