{"schemaVersion":"jobsearcher.job.v1","id":"9ab458ee7a689cc1befaddbe","url":"https://jobsearcher.com/jobs/9ab458ee7a689cc1befaddbe","canonicalUrl":"https://jobsearcher.com/jobs/9ab458ee7a689cc1befaddbe","title":"Quality Control Analyst","description":"*Job Description*\n\nJob Summary:\n\nThe QC Analyst will support the establishment and growth of client’s QC department. Responsibilities will include, but not limited to, performing QC testing of DS/DP release and stability samples in support of Client programs ensuring compliance with established standards; cross-training with Analytical Development (AD) to enable assay transfer to QC and assay validation activities; and authoring and reviewing of method SOPs, protocols and reports.\n\nResponsibilities:\n\n• Execute Drug Substance and Drug Product release and stability testing in support of Phase I, II, III and commercial manufacturing of biotechnology products.\n\n• Draft and execute Method Qualification/ Validation Protocols.\n\n• Complete documentation needed to support testing procedures including data capture forms, equipment logbooks, or inventory forms.\n\n• Interpret test results, compare them to established specifications and control limits, and make recommendations on appropriateness of data for release.\n\n• Write or revise Standard Operating Procedures, Work Instructions, Standard Test Methods and Forms.\n\n• Generate Method Validation and Deviation/Out of Specification reports, Change Control requests and CAPAs.\n\n• Monitor testing procedures to ensure that all tests are performed according to established item specifications, standard test methods, or protocols.\n\n• Train other analysts to perform laboratory procedures and assays.\n\n• Serve as a technical liaison between quality control and other departments, vendors, or contractors.\n\n• Participate in functional teams with various experience levels and provide input as needed on assay issues.\n\n• Supply quality control data necessary for regulatory submissions.\n\n• Evaluate new technologies and methods to make recommendations regarding their use.\n\n• Ensure that lab cleanliness and safety standards are maintained.\n\n• Identify and troubleshoot equipment problems.\n\n• Evaluate analytical methods and procedures to determine how they might be improved.\n\n• Support QC laboratory inspection readiness strategy and activities.\n\nEducation & Experience:\n\n• Bachelor’s degree and hands on-experience in Compendial assays testing (pH, A280, Sub-Visible Particles, Appearance), Endotoxin (Kinetic Chromogenic) and ELISAs.\n\n• Experience with large molecules.\n\n• Hands on experience in housekeeping of GMP QC Laboratories.\n\nRequired Knowledge, Skills & Abilities:\n\n• Excellent verbal and written communication skills, including technical writing.\n\n• Excellent organizational skills and attention to detail.\n\n• Proficiency with Microsoft Office Suite.\n\n• Strong level of initiative and quest for knowledge and growth.\n\n• Ability to prioritize and manage tasks and operational flexibility.\n\n• Ability to work well in a team and as an individual contributor.\n\n• Ability to function well in a high-paced and at times stressful environment.\n\nJob Type: Full-time\n\nPay: $12.58 - $22.77 per hour\n\nBenefits:\n* 401(k)\nSchedule:\n* 8 hour shift\n\nAbility to commute/relocate:\n* Frederick, MD 21701: Reliably commute or planning to relocate before starting work (Required)\n\nExperience:\n* large molecules: 1 year (Required)\n* GMP QC Laboratories: 1 year (Required)\n* pH, A280, Sub-Visible Particles, Appearance: 1 year (Required)\n* Kinetic Chromogenic) and ELISAs: 1 year (Required)\n\nShift availability:\n* Day Shift (Preferred)\n* Night Shift (Preferred)\n* Overnight Shift (Preferred)\n\nWork Location: In person","company":"TekTree","rawCompany":"tektree","city":"Frederick","state":"MD","isRemote":false,"isActive":false,"createdAt":"2026-11-09T09:28:18.082Z","occupations":[{"code":"19-4099.01","title":"Quality Control Analysts","slug":"quality-control-analysts"},{"code":"19-4031.00","title":"Chemical Technicians","slug":"chemical-technicians"},{"code":"11-3051.01","title":"Quality Control Systems Managers","slug":"quality-control-systems-managers"}],"industries":[{"code":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"},{"code":"325413","title":"In-Vitro Diagnostic Substance Manufacturing","slug":"in-vitro-diagnostic-substance-manufacturing"},{"code":"541714","title":"Research and Development in Biotechnology (except Nanobiotechnology)","slug":"research-and-development-in-biotechnology-except-nanobiotechnology"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Quality Control Analyst","description":"*Job Description*\n\nJob Summary:\n\nThe QC Analyst will support the establishment and growth of client’s QC department. Responsibilities will include, but not limited to, performing QC testing of DS/DP release and stability samples in support of Client programs ensuring compliance with established standards; cross-training with Analytical Development (AD) to enable assay transfer to QC and assay validation activities; and authoring and reviewing of method SOPs, protocols and reports.\n\nResponsibilities:\n\n• Execute Drug Substance and Drug Product release and stability testing in support of Phase I, II, III and commercial manufacturing of biotechnology products.\n\n• Draft and execute Method Qualification/ Validation Protocols.\n\n• Complete documentation needed to support testing procedures including data capture forms, equipment logbooks, or inventory forms.\n\n• Interpret test results, compare them to established specifications and control limits, and make recommendations on appropriateness of data for release.\n\n• Write or revise Standard Operating Procedures, Work Instructions, Standard Test Methods and Forms.\n\n• Generate Method Validation and Deviation/Out of Specification reports, Change Control requests and CAPAs.\n\n• Monitor testing procedures to ensure that all tests are performed according to established item specifications, standard test methods, or protocols.\n\n• Train other analysts to perform laboratory procedures and assays.\n\n• Serve as a technical liaison between quality control and other departments, vendors, or contractors.\n\n• Participate in functional teams with various experience levels and provide input as needed on assay issues.\n\n• Supply quality control data necessary for regulatory submissions.\n\n• Evaluate new technologies and methods to make recommendations regarding their use.\n\n• Ensure that lab cleanliness and safety standards are maintained.\n\n• Identify and troubleshoot equipment problems.\n\n• Evaluate analytical methods and procedures to determine how they might be improved.\n\n• Support QC laboratory inspection readiness strategy and activities.\n\nEducation & Experience:\n\n• Bachelor’s degree and hands on-experience in Compendial assays testing (pH, A280, Sub-Visible Particles, Appearance), Endotoxin (Kinetic Chromogenic) and ELISAs.\n\n• Experience with large molecules.\n\n• Hands on experience in housekeeping of GMP QC Laboratories.\n\nRequired Knowledge, Skills & Abilities:\n\n• Excellent verbal and written communication skills, including technical writing.\n\n• Excellent organizational skills and attention to detail.\n\n• Proficiency with Microsoft Office Suite.\n\n• Strong level of initiative and quest for knowledge and growth.\n\n• Ability to prioritize and manage tasks and operational flexibility.\n\n• Ability to work well in a team and as an individual contributor.\n\n• Ability to function well in a high-paced and at times stressful environment.\n\nJob Type: Full-time\n\nPay: $12.58 - $22.77 per hour\n\nBenefits:\n* 401(k)\nSchedule:\n* 8 hour shift\n\nAbility to commute/relocate:\n* Frederick, MD 21701: Reliably commute or planning to relocate before starting work (Required)\n\nExperience:\n* large molecules: 1 year (Required)\n* GMP QC Laboratories: 1 year (Required)\n* pH, A280, Sub-Visible Particles, Appearance: 1 year (Required)\n* Kinetic Chromogenic) and ELISAs: 1 year (Required)\n\nShift availability:\n* Day Shift (Preferred)\n* Night Shift (Preferred)\n* Overnight Shift (Preferred)\n\nWork Location: In person","datePosted":"2026-11-09T09:28:18.082Z","dateModified":"2026-11-09T09:28:18.082Z","hiringOrganization":{"@type":"Organization","name":"TekTree","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Frederick","addressRegion":"MD","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"9ab458ee7a689cc1befaddbe"},"url":"https://jobsearcher.com/jobs/9ab458ee7a689cc1befaddbe"}}