{"id":797829,"url":"https://alion.io/job/procapslabs-quality-control-method-development-specialist","title":"Quality Control Method Development Specialist","company":{"id":687712,"name":"2026 ProCaps Laboratories, Inc.","domain":"procapslabs.com","url":"https://alion.io/company/procapslabs","size_band":null,"is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workable","truth_index":{"grade":"A","score":100,"open_postings":6,"ghost_share":0,"stale_share":0,"repost_share":0,"time_to_fill_p50_days":null,"computed_at":"2026-09-27T05:45:00Z"}},"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":["Henderson, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":52000,"max_usd":128000,"period":"year","method":"role_country_seniority_unknown","sample_n":4852},"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Microsoft Office","optional":false}],"status":"live","first_seen_at":"2026-08-14T00:00:00Z","employer_posted_date":"2026-08-14","last_verified_at":"2026-09-27T22:17:30Z","board_verified":true,"closed_at":null,"days_open":45,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":45},"description":"The Quality Control Method Development Specialist is responsible for providing technical leadership for analytical method development, optimization, validation, verification, and transfer activities in support of ISO/IEC 17025 accreditation requirements, cGMP compliance, and laboratory quality system objectives. This position serves as the laboratory subject matter expert for analytical methodologies and instrumentation, including HPLC, GC, ICP-MS, HPTLC, UV/Vis, Protein Analyzer, and other laboratory technologies.\nThe Method Development Specialist supports implementation of new analytical technologies, leads technical aspects of laboratory investigations, develops and executes validation protocols, and collaborates with Quality Control Operations, Product Development, Quality Assurance, and other stakeholders to ensure analytical methods are scientifically sound, compliant, and fit for intended use.\nThis role is a key member of the Quality Control Compliance Team and plays a critical role in maintaining accreditation, reducing validation backlogs, improving data quality, and supporting continuous improvement initiatives.\nRequirements\nMINIMUM JOB QUALIFICATIONS AND REQUIREMENTS\nBachelor’s degree in chemistry, Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or another natural or physical science. \n3+ years of experience in analytical method development, validation, or laboratory quality control. \nDemonstrated experience with analytical method development and validation. \nExperience working in a regulated laboratory environment. \nStrong understanding of analytical chemistry principles and laboratory investigations. \nProficiency with Microsoft Office applications.\nStrong working knowledge and experience in HPLC, GC, ICP-MS, UV/VIS, HPTLC or similar laboratory instrumentation\nFamiliar with USP, AOAC, ICH, ISO/IEC 17025 and other analytical method development bodies\nOTHER ESSENTIAL JOB DUTIES AND RESPONSIBILITIES\nDevelop, optimize, implement, and troubleshoot analytical methods for raw materials, in-process materials, finished products, stability programs, and new product formulations.\nAdapt USP, AOAC, customer, regulatory, and published methods for existing laboratory instrumentation and applications.\nDesign and execute method validation, verification, transfer, equivalency, and performance studies.\nPrepare validation protocols, reports, technical assessments, and supporting documentation while maintaining validation master plans and roadmaps.\nEstablish scientifically justified acceptance criteria and validation parameters.\nLead the implementation, qualification, verification, and integration of new analytical instrumentation and technologies.\nDevelop methodologies and procedures for emerging technologies, including HPTLC and Protein Analyzer platforms.\nIdentify and implement opportunities to improve testing efficiency, accuracy, throughput, and automation.\nServe as the laboratory subject matter expert for analytical methods, instrumentation, data interpretation, and technical troubleshooting.\nProvide technical support, training, competency development, mentoring, and problem-solving guidance to laboratory personnel.\nLead technical assessments and investigations related to OOS, OOT, atypical results, and laboratory nonconformances.\nSupport root cause analyses, CAPA development, analytical data reviews, trend evaluations, and continuous method improvement.\nEnsure method development, validation, and laboratory activities comply with ISO/IEC 17025, cGMP, data integrity, and applicable regulatory requirements.\nSupport audits, accreditation assessments, regulatory inspections, internal audits, and maintain audit-ready documentation.\nDrive quality system improvements by reducing validation backlogs, improving laboratory performance metrics, enhancing method robustness and efficiency, supporting timely investigations, and contributing to continuous audit readiness and compliance.\nWORK ENVIRONMENT\nWork is performed primarily in a smoke-free laboratory and office environment. \nExposure to chemicals, laboratory equipment, and production areas may occur. \nAppropriate personal protective equipment (PPE) must be worn when required.\nPHYSICAL REQUIREMENTS\nFrequent sitting, standing, walking, and climbing\nAble to lift up to 25 lbs.\nBenefits\nProCaps provides :\n A competitive salary!\nTop-Tier Medical, Dental & Vision Coverage - $0 when you qualify for the Wellness Program!\nPaid Time Off, Eight (8) Company Holidays \n401(k) with Company Match - up to 4.5%\n100% Company Life Coverage \n100% Short Term Disability Coverage\nGym Membership Reimbursement \nVitamin Allowance + Discounts \nCompany-Funded Health Savings Account ($1,600/year)\nCash Reward Employee Referral Program \nPet Insurance \n*** Fantastic work environment that focuses on Safety, Quality, Community, and amazing people. We hire top talent and celebrate the ingenuity and tenacity of our team members and leaders!","description_format":"text","description_chars":4947,"description_truncated":false,"requirements":{"experience_years_min":null,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":null,"security_clearance":false,"languages":[]},"benefits":["Gym membership"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Dietary Supplements"],"lifecycle":[{"event":"open","at":"2026-09-12T06:26:32Z"}],"liveness":{"score":17,"band":"cold","label":"Long shot","p_open":1,"p_active":0.482,"p_room":0.35,"age_days":44,"expected_fill_days":21,"reasons":["conf:0","win:tail"],"computed_at":"2026-09-27T05:45:00Z"},"pay":null,"html_url":"https://alion.io/job/procapslabs-quality-control-method-development-specialist","json_url":"https://alion.io/job/procapslabs-quality-control-method-development-specialist.json","meta":{"generated_at":"2026-09-28T00:54:28Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","usage":{"tier":"crawler","counted_by":"address","units_charged":1,"used_today":460,"day_limit":5000,"remaining_today":4540,"minute_limit":60,"resets_at":"2026-09-29T00:00:00Z"}}}