{"id":1331623,"url":"https://alion.io/job/celldex-quality-assurance-associate-ii","title":"Quality Assurance Associate II","company":{"id":3786145,"name":"celldex","domain":"celldex.com","url":"https://alion.io/company/celldex","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"iCIMS","truth_index":null},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"middle","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Fall River, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":66413,"max":86250,"currency":"USD","period":"year","gross":null,"usd_annual":86250},"salary_estimate":null,"experience_years_min":4,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Microsoft Office","optional":false},{"name":"SharePoint","optional":false}],"status":"live","first_seen_at":"2026-09-27T10:18:19Z","employer_posted_date":"2026-09-27","last_verified_at":"2026-10-12T10:30:28Z","board_verified":true,"closed_at":null,"days_open":15,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":15},"description":"About Celldex\nCelldex is pioneering new horizons in immunology to deliver life-changing therapies. We are relentless in our pursuit of novel antibody-based treatments that engage the human immune system and directly affect critical pathways to improve the lives of patients with allergic, inflammatory and autoimmune disorders. We have built a culture where innovative and talented people thrive-focusing a significant effort on attracting and retaining passionate and motivated employees who want to play a role in helping people with serious health conditions and who see this effort as personally rewarding. In our highly entrepreneurial environment, employees are empowered and the opportunity for professional development occurs every day.\nOverview\nThe Quality Assurance Associate II performs documentation activities associated with manufacturing operations while ensuring compliance with GXP quality systems.\nResponsibilities\nDocument ManagementElectronic Document Management System (EDMS) workflow coordinator for GMP documentation and other GxP documentation, as needed\nDocument formatting and review\nAttachment issuance support, that includes, but is not limited to, issuing and reconciling Batch Records, Solution Records and Validation Testing documentation and maintaining tracking tools, both hard copy and electronic \nAssignment of raw material part numbers\nSupport raw material and product release\nLabel generation\nMaintenance of label and ribbon inventory and scheduling annual maintenance of labeling machines\nWrite/revise QA SOPs and reports, as related to document control\nMaintain, scan and archive Quality Assurance documentation \nReport on Vendor Change Notifications to determine their effects, if any, on manufacturing\nResponsible for organizing and maintaining off-site storage shipments for Fall River\n\nTraining Program SupportPerform internal training, including, but not limited to, off-site storage preparation\nMaintain training documentation including the hard copies and the electronic training files in SharePoint, as needed\nAssist with the annual audit of training files\n\nAuditorConduct annual documentation audits\nSupport internal GMP audits\nSupport external audit documentation requests\n\nOther related job functions and QA support as needed\nQualifications\nAssociate Degree with 2+ years GMP experience or 4+ years GMP experience without a degree\nDocument Management experience in GMP environment preferred\nBroad knowledge of GMP and other GxP quality systems, policies, and regulations\nStrong communication and organizational skills\nProficiency using MS Office Suite\nProficiency using an EDMS\nThe ability to multi-task and manage and prioritize workload in a proactive manner\nThe ability to take initiative, maintain confidentiality, meet deadlines, and work independently and as part of a team\nCompensation Statement\nThe expected base salary for this position is: $66413.00 to $86250.00. We are committed to compensating employees equitably based on several factors including experience, education, licensure/certifications, skill level, location of the position, and availability of similar talent in a competitive market. Subject to eligibility and applicable plan terms, compensation includes base salary, annual discretionary bonus, long term incentive, 401(K) plan with employer contribution, health care and other insurance benefits (for employee and family), paid holidays, vacation, and sick days. A summary of our benefits can be found on our careers page Celldex is proud to be an equal opportunity employer that strives to foster a culture of diversity, equity, and inclusion. We are committed to promoting a diverse environment through development, recruiting and community outreach.","description_format":"text","description_chars":3732,"description_truncated":false,"requirements":{"experience_years_min":4,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"associate","optional":false},"security_clearance":false,"languages":[]},"benefits":["Equity","Professional development"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Biotechnology","Health Care","Professional Services"],"lifecycle":[{"event":"open","at":"2026-09-27T10:18:19Z"}],"visa":[],"liveness":{"score":73,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.812,"p_room":0.9,"age_days":14,"expected_fill_days":24,"reasons":["conf:2","win:mid"],"computed_at":"2026-10-12T06:55:09Z"},"pay":{"stated_usd_annual":86250,"is_top_pay":false},"html_url":"https://alion.io/job/celldex-quality-assurance-associate-ii","json_url":"https://alion.io/job/celldex-quality-assurance-associate-ii.json","meta":{"generated_at":"2026-10-12T14:39:35Z","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":23068,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-13T00:00:00Z"}},"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":3786145},"rest":"https://alion.io/mcp/rest/get_company?id=3786145"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fcelldex-quality-assurance-associate-ii"},{"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%2Fcelldex-quality-assurance-associate-ii"},{"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%2Fcelldex-quality-assurance-associate-ii"},{"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/celldex-quality-assurance-associate-ii\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fcelldex-quality-assurance-associate-ii"}]}