{"id":238283,"url":"https://alion.io/job/care-specialist-quality-assurance","title":"Specialist, Quality Assurance","company":{"id":19845,"name":"Care Access","domain":"careaccess.com","url":"https://alion.io/company/care","size_band":"501-1000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Greenhouse","truth_index":{"grade":"B","score":84,"open_postings":4,"ghost_share":0,"stale_share":0.5,"repost_share":0.25,"time_to_fill_p50_days":53,"computed_at":"2026-10-19T05:45:15Z"}},"role":"Sales","role_family":"Sales","seniority":"middle","employment_type":null,"work_mode":"remote","remote_scope":"stated_countries","remote_scope_basis":"board_field","remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["United States"],"countries":["US"],"hiring_countries":["US"],"hiring_countries_total":1,"salary":{"min":70000,"max":90000,"currency":"USD","period":"year","gross":null,"usd_annual":90000},"salary_estimate":null,"experience_years_min":4,"visa_sponsorship":true,"relocation_package":false,"has_equity":false,"technologies":[{"name":"GCP","optional":false}],"status":"closed","first_seen_at":"2026-08-25T20:44:55Z","employer_posted_date":"2026-10-02","last_verified_at":"2026-10-16T14:36:08Z","board_verified":false,"closed_at":"2026-10-16T14:36:08Z","days_open":51,"trust":{"level":"not_scored","repost_count":null,"flags":[],"days_open":51},"description":"About Care Access\nCare Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly to communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow.\nWith programs like Future of Medicine, which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers, which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all.\nTo learn more about Care Access, visit www.CareAccess.com.\nHow This Role Makes a Difference\nCare Access is seeking a dedicated, experienced, and innovation-driven Quality Assurance Specialist (GxP) to support the success of the Quality Assurance Department and organizational compliance activities. The Quality Assurance Specialist will be responsible for closely monitoring the quality and compliance of clinical work at both traditional trial sites and decentralized trials. The QA specialist will directly support quality initiatives, audit functions, CAPA systems and promote inspections readiness. Working in support of the Associate Director of Quality Assurance, the Quality Assurance Specialist will ensure that Care Access maintains a high level of quality while executing clinical trials according to Care Access SOPs, GCP, and FDA/ICH Guidelines.\nHow You'll Make An Impact\nSite-Level Quality & Data Integrity: Ensure the highest standards of patient safety and data integrity at clinical research sites through regular quality assurance reviews, interpreting and implementing standard QA procedures. \nGCP Regulatory Document Review: Conduct comprehensive reviews of study-specific regulatory binders and clinical documents to verify they are accurately completed, submitted, and maintained per GCP standards. \nAudit Execution & Tracking: Execute the yearly corporate audit plan, systematically tracking quality assurance audits, monitoring related activities, and preparing detailed outcome reports for management. \nIssue Resolution & CAPA Management: Partner directly with research staff and Principal Investigators (PIs) to resolve identified compliance issues, developing, tracking, and monitoring Corrective and Preventative Action (CAPA) plans. \nExternal Audit & Inspection Support: Coordinate and provide hands-on operational support for on-site audits and inspections conducted by external providers, sponsors, and regulatory agencies. \nQuality Systems Administration: Provide ongoing administrative support to the Quality Department by maintaining internal quality systems, compliance trackers, and operational programs. \nSOP Development & Maintenance: Participate in the routine review, drafting, and maintenance of quality assurance Standard Operating Procedures (SOPs) to ensure alignment with evolving regulations. \nCross-Functional Compliance Advisory: Act as an internal quality resource to provide ongoing guidance and best-practice recommendations to site personnel and clinical project teams. \nRegulatory compliance: be knowledgeable of evolving GxP guidelines. Ability to critically think, eagerness to learn, and commitment to ensuring compliance. Knowledge of and able to interpret regulatory guidance’s such as 21 CFR Part 11/ Part 312, ICH GCP E6 (R3). \n Inspection readiness: promote a culture of inspections readiness and continuous improvement. Be flexible to work with risk-based audit agendas and shifting priorities. \nCreate and deliver training on Quality and Improvement activities \nSupport completion of RFP/RFI (Request for proposals/information) \nWillingness to learn and engage with digital technologies \nProvide AI project quality support and consultation \nSupport other activities related to the management of QMS and accuracy of data \nSupport GxP and non GxP quality issues and/or projects needing quality consultation and support \nThe Expertise Required \nExcellent working knowledge of medical and research terminology \nExcellent working knowledge of federal regulations and good clinical practices (GCP) \nAttention to detail \nAbility to communicate and work effectively with a diverse team of professionals \nStrong Organizational Skills: Able to prioritize, delegate, direct, support and evaluate others’ work and follow through on assignments \nCommunication Skills: Strong verbal and written communication skills as evidenced by positive interactions with coworkers, management, clients and vendors \nTeam Collaboration Skills: Work effectively and collaboratively with other team members to accomplish mutual goals. Bring a positive and supportive attitude to achieving these goals \nStrong computer skills with demonstrated abilities using clinical trials database, IVR systems, electronic data capture, MS word and excel Ability to balance tasks with competing priorities \nDemonstrate decision making skills Curiosity and passion to learn, innovate, able to communicate any possible risks and get things done \nFriendly, outgoing personality with the ability to maintain a positive attitude under pressure \nHigh level of self-motivation and energy \nAbility to work independently in a fast-paced environment with minimal supervision \nMust have a client service mentality \nExperience with supporting multiple sites and identifying gaps \nExperience with internal and external audits: FDA, GCP, SOPs \nCertifications/Licenses, Education, and Experience\nMinimum Education:Bachelor’s degree \n\nMinimum Experience:2 years of experience in Quality Assurance \n4 years of experience in Clinical Research working in a compliance or GCP relevant role \n\nHow We Work Together\nLocation: Remote within the United States. This role requires 100% of work to be performed in a remote office environment.\nTravel: This is a remote position with up to 35% travel requirements. Must have the ability to travel. International travel may also be required as part of the role. \nPhysical demands associated with this position Include: The ability to use keyboards and other computer equipment.\nThe expected pay range for this role is $70,000 - $90,000 USD per year for full time team members.\nBenefits & Perks (US Full Time Employees)\nPaid Time Off (PTO) and Company Paid Holidays\n100% Employer paid medical, dental, and vision insurance plan options\nHealth Savings Account and Flexible Spending Accounts\nBi-weekly HSA employer contribution\nCompany paid Short-Term Disability and Long-Term Disability\n401(k) Retirement Plan, with Company Match \nMandatory Employer Disclosures\nNotice to Illinois applicants: Applicants are not obligated to disclose expunged juvenile records or adjudication, arrest, or conviction.\nNotice to Connecticut applicants: Care Access may require applicants to submit to a urinalysis drug test in connection with an application for employment.\nNotice to Arizona, Georgia, Indiana, and North Dakota applicants: Care Access complies with applicable laws prohibiting smoking in and around places of employment.\nNotice to Massachusetts applicants: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.\nNotice to Rhode Island applicants: Care Access complies with Rhode Island law prohibiting smoking in enclosed areas within places of employment. Care Access is also subject to is subject to Chapters 29-38 of Title 28 of the Rhode Island General Laws.\nNotice to Maryland applicants: UNDER MARYLAND LAW, AN EMPLOYER MAY NOT REQUIRE OR DEMAND, AS A CONDITION OF EMPLOYMENT, PROSPECTIVE EMPLOYMENT, OR CONTINUED EMPLOYMENT, THAT AN INDIVIDUAL SUBMIT TO OR TAKE A LIE DETECTOR OR SIMILAR TEST. AN EMPLOYER WHO VIOLATES THIS LAW IS GUILTY OF A MISDEMEANOR AND SUBJECT TO A FINE NOT EXCEEDING $100. \nDiversity & Inclusion\nWe work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission. \nWe are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.\nCare Access is unable to sponsor work visas at this time.\nIf you need an accommodation to apply for a role with Care Access, please reach out to: ","description_format":"text","description_chars":9209,"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":["Retirement plans","Vision insurance"],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Clinical Trial Sites & Recruitment"],"lifecycle":[{"event":"open","at":"2026-09-05T10:15:42Z"},{"event":"close","at":"2026-10-16T14:36:08Z"}],"visa":[],"liveness":null,"pay":{"stated_usd_annual":90000,"is_top_pay":false},"html_url":"https://alion.io/job/care-specialist-quality-assurance","json_url":"https://alion.io/job/care-specialist-quality-assurance.json","meta":{"generated_at":"2026-10-19T16:07:57Z","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":12159,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-20T00:00:00Z"}},"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":19845},"rest":"https://alion.io/mcp/rest/get_company?id=19845"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fcare-specialist-quality-assurance"},{"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%2Fcare-specialist-quality-assurance"},{"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%2Fcare-specialist-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/care-specialist-quality-assurance\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fcare-specialist-quality-assurance"}]}