{"id":2094849,"url":"https://alion.io/job/cai-qa-specialist","title":"QA Specialist","company":{"id":3866618,"name":"CAI","domain":"caiready.com","url":"https://alion.io/company/caiready","size_band":"501-1000","is_staffing_agency":false,"employer_type":"staffing","is_intermediary":false,"listed_via":null,"ats_vendor":"Lever","truth_index":{"grade":"D","score":53,"open_postings":81,"ghost_share":0.79,"stale_share":0,"repost_share":0,"time_to_fill_p50_days":null,"computed_at":"2026-10-10T05:45:15Z"}},"role":"QA","role_family":"QA","seniority":"junior","employment_type":"contractor","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Melbourne, Australia"],"countries":["AU"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":null,"experience_years_min":2,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-04-15T04:20:17Z","employer_posted_date":"2026-04-15","last_verified_at":"2026-10-12T00:37:25Z","board_verified":true,"closed_at":null,"days_open":179,"trust":{"level":"ghost","repost_count":0,"flags":["stale","company_stale"],"days_open":179},"description":"CAI Overview\nAre You Ready?\nCAI is a professional services company established in 1996 that has grown year over year to nearly 800 people worldwide. For Life Sciences and Mission Critical industries that need to deliver critical solutions in high-stakes environments, we provide accelerated operational readiness and unparalleled performance at the highest standard through our rigorous approach, field-tested processes, and elite expertise developed over 30 years.\nOur approach is simple because our Purpose informs everything we do:\nWe exist to be the trusted solution for our clients as they strive to build a better working world and improve the human experience.\nAt CAI, we are committed to living our Foundational Principles, both professionally and personally:\nWe act with integrity\nWe serve each other\nWe serve society\nWe work for our future\nAt CAI, we believe in a relentless dedication to excellence, pushing boundaries and surpassing expectations. From the beginning, we’ve challenged ourselves to do what others wouldn’t. Not just setting industry standards, but redefining them entirely. We are bold in our thinking and creative in our approach. We operate at the intersection of wisdom and technology and thrive when they come together with humanity. For us, operational readiness isn’t simply a goal. It’s a way of life. Because tomorrow demands to be at the forefront of today. We do this through tireless effort, precision, efficiency and an unwavering belief that there is always room for advancement. We’re not interested in how it used to be done. We’re obsessed with how it will be done.\nRequirements include:\nPosition Description:\nValidation:\nWork closely with the Validation manger to ensure completion of validation goals and objectives.\nSupport validation projects from initiation to completion, ensuring they are delivered on time and within budget. This requires coordinating with cross-functional teams and maintaining clear communication throughout the project lifecycle.\nSupport the testing and validation of equipment, cleaning processes, analytical processes, and software.\nSupport the development and implementation of validation plans, protocols, and procedures.\nEvaluate and approve validation plans, protocols, and reports to ensure completeness and accuracy.\nWithin validation projects ensure that all aspects of validation, testing, and documentation are completed in a timely and efficient manner.\nUtilisation of effective risk management is crucial for maintaining product quality and compliance.\nIdentify potential risks associated with validation processes and support the development of mitigation strategies.\nConduct risk assessments to identify potential issues in products and processes.\nEstablish and maintain validation procedures and processes that meet company policies and applicable regulations.\nWork to schedules for validation activities to ensure timely execution and completion.\nParticipate in the tracking, reporting and trending validation activities and results.\nEnsure management is aware of validation department performance, trends in products/processes, and changes that could impact the facility.\nTrack & trend processes to monitor validation department performance.\nWork closely with cross-functional teams to resolve validation issues and to ensure all products and processes are validated accurately and efficiently. Ensure validation activities are integrated into the overall project lifecycle.\nSupport compilation and review of Product Quality Reviews/ Annual Product Reviews, as appropriate.\nCommunicate with internal and external stakeholders regarding projects, products, and other validation related topics.\nPerforms other job-related duties as assigned.\nRegulatory Compliance:\nResponsible for compliance with relevant regulations, legislation, and standards.\nSupport preparation efforts for regulatory inspections and audits related to validation activities.\nSupport the Generation of audit responses to observations in a clear and wholistic manner\nSupport company Data integrity program.\nSupport the inspection readiness program.\nKnowledge of relevant TGA and regulatory guidelines to ensure cGMP compliance.\nTraining and Development:\nProactively foster an open, supportive, values-based culture, and work environment.\nUtilise a broad understanding of cGMP to provide Validation support, mentoring and coaching for Quality, Operations, Analytical, Logistics and Engineering departments to assure that activities are undertaken in compliance with cGMP and internal procedures, as appropriate.\nOther Duties:\nIdentify continuous improvement opportunities and implement solutions to improve programs and meet business goals.\nParticipating in Internal meetings/events/activities as required.\nRequirement:\nA bachelor’s degree in a relevant field such as engineering, life sciences, or quality assurance is essential. Advanced degrees or certifications in validation or quality systems can be advantageous.\nDemonstrated experience in Validation in a relevant or related industry.\nA minimum of 2 years of experience in validation, quality assurance, or a related field is required.\nStrong understanding of FDA, EMA, and ISO regulations including PDA and ISPE pertinent to validation activities is crucial.\nProficiency in validation management software such or similar tools is required. Experience with electronic documentation systems and risk management tools is also beneficial.\nGood project management skills are necessary for supporting validation projects effectively.\nExcellent analytical skills are required to assess validation data and identify trends.\nFamiliarity with relevant technology and systems used in validation processes is necessary. This includes understanding software validation, equipment qualification, and process validation techniques\nThe ability to adapt to changing regulations, technologies, and industry standards is crucial for success in this role.\nGood knowledge CGMP and GMP regulatory requirements nationally and internationally as required.\nExcellent attention to detail and decision making skills.\nDemonstrated knowledge and understanding of quality management principles, and a commitment to fostering a culture of quality and compliance.","description_format":"text","description_chars":6246,"description_truncated":false,"requirements":{"experience_years_min":2,"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","Professional Services","Science & Engineering"],"lifecycle":[{"event":"open","at":"2026-10-08T16:22:48Z"}],"visa":[],"liveness":{"score":5,"band":"cold","label":"Long shot","p_open":1,"p_active":0.191,"p_room":0.28,"age_days":178,"expected_fill_days":23,"reasons":["conf:2","stale_co","ghost","win:tail","crowd:junior"],"computed_at":"2026-10-10T05:45:15Z"},"pay":null,"html_url":"https://alion.io/job/cai-qa-specialist","json_url":"https://alion.io/job/cai-qa-specialist.json","meta":{"generated_at":"2026-10-12T02:10:41Z","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":3072,"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":3866618},"rest":"https://alion.io/mcp/rest/get_company?id=3866618"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fcai-qa-specialist"},{"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%2Fcai-qa-specialist"},{"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%2Fcai-qa-specialist"},{"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/cai-qa-specialist\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fcai-qa-specialist"}]}