{"id":2478283,"url":"https://alion.io/job/inteldot-specialist-qa-35768","title":"Specialist QA 35768","company":{"id":4418608,"name":"Inteldot","domain":"inteldot.com","url":"https://alion.io/company/inteldot","size_band":"51-200","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Breezy","truth_index":null},"role":"Science & Research","role_family":"Science & Research","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":["Juncos, Puerto Rico"],"countries":["PR"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":51000,"max_usd":120000,"period":"year","method":"global_role_cell_scaled_by_country","sample_n":760},"experience_years_min":4,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"closed","first_seen_at":"2026-10-05T14:48:33Z","employer_posted_date":"2026-10-05","last_verified_at":"2026-10-20T14:47:43Z","board_verified":false,"closed_at":"2026-10-20T14:47:43Z","days_open":14,"trust":{"level":"not_scored","repost_count":null,"flags":[],"days_open":14},"description":"Inteldot has over 15 years in the life sciences industry, with operations across Puerto Rico, the United States, Europe, and Japan. This is a great opportunity for one of our leading clients in Puerto Rico.\nNon-Standard Shift (12 working hours)\nJob Description:\nUnder minimal supervision, support Quality Assurance program by performing a variety of key responsibilities in manufacturing, process validation, regulatory compliance, and quality assurance activities.\nRequirements & Qualifications:\nPerform On-the-floor Plant Quality Assurance (PQA) review, approval, and tracking of cGMP processes, procedures, testing methods in manufacturing, documents and records, batch record review, MES, EBR, SAP, EDMQ, DQMS, Trackwise; including but not limited to deviations, CAPAs, and validations.\nActively engage in continuous improvement initiatives, programs, and projects.\nVigilantly ensure that changes potentially impacting product quality are assessed according to procedures.\nCertify that deviations from established procedures are investigated and documented per procedures and ensure on-the-floor triage is completed, documented, and current procedural controls are achieved, including ensuring the initiation of deviation records.\nEnsure that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements.\nRequire strong collaboration and cross-functional partnership to ensure the Quality Management System, Manufacturing, Process Development, Validation, Quality Control, Warehouse, Engineering, Contractors, Environmental, Facilities, and other processes are executed according to established procedures.\nServe as a strategic advisor to senior management regarding quality, compliance, supply, and safety risks.\nSupport internal/external audits and inspections as part of the audit/inspection management team, including acting as Quality unit representative as needed.\nAccountable for adherence to assigned training, permitting execution of required tasks.\nChampion continuous improvement initiatives and projects.\nProvide support and oversight for New Product Introduction (NPI).\nDemonstrate validated expertise in Quality Systems such as deviations, CAPA, and change control.\nExhibit experience in computer systems validation or computer systems quality assurance, particularly with medical devices and/or consulting background technical proficiency.\nPossess robust knowledge and experience with processes involved in manufacturing and distribution, QA, QAL, and Process Development.\nExperience with validation of GxP applications, including development of Validation Master Plan, Installation Qualification (IQ), Risk Assessment/GxP assessment, Operational Qualification (OQ), and Performance Qualification (PQ) protocols, test scripts, and completion/summary report approvals per compliance requirements.\nValidated experience serving as Quality Contact for complex projects involving new products.\nValidated experience in commissioning and qualification.\nStrong organizational skills, including the ability to follow assignments through to completion.\nEnhanced skills in leading, influencing, and negotiating.\nDemonstrate the ability to interact effectively with regulatory agencies.\nSolid word processing, presentation, database, and spreadsheet application skills.\nStrong communication skills in English and Spanish (both written and oral), facilitation, and presentation skills.\nFunctions:\nReview and approve product MPs.\nApprove process validation protocols and reports for manufacturing processes.\nRequest Quality on incident triage team.\nApprove Environmental Characterization reports.\nRelease of sanitary utility systems.\nApprove planned incidents.\nRepresent QA on NPI team.\nLead investigations.\nLead site audits.\nOwn site quality program procedures.\nDesignee for QA manager on local CCRB.\nReview Risk Assessments.\nSupport Automation activities.\nSupport facilities and environmental programs.\nReview and approve Work Orders.\nReview and approve EMS/BMS alarms.\nApprove NC investigations and CAPA records.\nApprove change controls.\nProvide lot disposition and authorize lots for shipment\nEducation\n Bachelor's in science or engineering+ 4 years of directly related experience","description_format":"text","description_chars":4260,"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":[{"language":"Spanish","level":"All levels","optional":false},{"language":"English","level":"All levels","optional":false}]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":[],"lifecycle":[{"event":"open","at":"2026-10-13T22:00:28Z"},{"event":"close","at":"2026-10-20T14:47:43Z"}],"visa":[],"liveness":null,"pay":null,"html_url":"https://alion.io/job/inteldot-specialist-qa-35768","json_url":"https://alion.io/job/inteldot-specialist-qa-35768.json","meta":{"generated_at":"2026-10-21T04:49:18Z","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 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