{"id":2981459,"url":"https://alion.io/job/frontage-laboratories-associate-qc-specialist","title":"Associate QC Specialist","company":{"id":3783210,"name":"Frontage Laboratories","domain":"frontagelab.com.cn","url":"https://alion.io/company/frontagelab","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"ADP","truth_index":{"grade":"C","score":66,"open_postings":69,"ghost_share":0.478,"stale_share":0,"repost_share":0,"time_to_fill_p50_days":90,"computed_at":"2026-11-03T05:54:40Z"}},"role":"Biotech","role_family":"Biotech","seniority":"junior","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Exton, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":49000,"max_usd":103000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":132},"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"ELISA","optional":false},{"name":"GLP","optional":false},{"name":"LIMS","optional":false},{"name":"Microsoft Excel","optional":false}],"status":"live","first_seen_at":"2026-10-15T20:42:00Z","employer_posted_date":"2026-10-15","last_verified_at":"2026-11-03T06:02:18Z","board_verified":true,"closed_at":null,"days_open":18,"trust":{"level":"ok","repost_count":0,"flags":["company_stale"],"days_open":18},"description":"Associate QC Specialist/QC Specialist/Sr. QC Specialist - Large Molecule\nFulltime\nExton PA\nFrontage Laboratories Inc. is an award winning, publicly listed (HKSE), full-service CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China, and growing over 30% YOY. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials.\nJob Summary\nThe QC Specialist supports quality control activities for large molecule (PK, PD, ADA, NAb, etc.) bioanalytical studies conducted in a GLP-regulated contract research organization (CRO) environment. This role is responsible for the independent quality review of bioanalytical data, laboratory documentation, and study reports to ensure accuracy, completeness, and compliance with Standard Operating Procedures (SOPs), Good Laboratory Practice (GLP), and sponsor requirements.\nThe position plays a key role in ensuring the integrity of data delivered to clients by reviewing analytical datasets, validating report content, and supporting preparation and quality control of data tables used in clinical and regulatory reports.\nKey Responsibilities\nBioanalytical Data QC Review\nPerform independent quality control review of biomarker bioanalytical data including laboratory notebooks, raw instrument data, electronic files, and Laboratory Information Management System (LIMS) records.\nVerify accuracy, traceability, completeness, and consistency of analytical data in accordance with SOPs, GLP regulations, and study protocols.\nIdentify discrepancies or documentation gaps and work with laboratory scientists and study teams to resolve issues prior to final reporting.\nStudy Report Review\nReview method development, qualification, and validation reports to ensure scientific accuracy and consistency between narrative text, tables, figures, and source data.\nReview bioanalytical sample analysis reports for completeness, data integrity, and compliance with internal procedures and client requirements.\nEnsure reported results are supported by verified raw data and documentation.\nData Tables and Client Deliverables\nPrepare and QC bioanalytical result tables for clinical study reports and biomarker testing reports.\nReview and interpret client Data Transfer Specifications (DTS) to ensure correct formatting, variable definitions, and dataset structure.\nGenerate, QC, and transmit client-ready datasets and data tables according to sponsor specifications and project timelines.\nData Integrity and Compliance\nEnsure all QC review activities maintain data integrity and meet regulatory expectations.\nMaintain documentation supporting QC review processes for audit and inspection readiness.\nAssist in maintaining standardized templates and QC checklists to support efficient report review.\nCross-Functional Collaboration\nCollaborate with laboratory scientists, project managers, data management teams, and quality assurance personnel to support timely study reporting and client deliverables.\nCommunicate QC findings clearly and track issue resolution to ensure high-quality final reports.\nAdditional Responsibilities\nSupport continuous improvement initiatives for QC processes and documentation standards.\nAssist with preparation for internal audits and regulatory inspections.\nPerform other duties as assigned.\nQualifications\nEducation\nBachelor’s degree in Biology, Biochemistry, Immunology, Pharmaceutical Sciences, or a related life sciences discipline.\nExperience and Qualification\n Associate QC Specialist: BS/MS in a life science with 0-2 years of experience in a bioanalytical laboratory (e.g., PK, ADA/immunogenicity, or PD/biomarker assays) or a quality control role in a CRO, pharmaceutical, or biotechnology environment.\n QC Specialist: BS with 2-5 years (or MS with 1-3 years) of the experience above, including work in a regulated (GLP/GCLP/GxP) environment.\n Sr. QC Specialist: BS with 5+ years of QC experience in a CRO, pharmaceutical, or biotechnology environment, or 3+ years of experience as a scientist in a bioanalytical laboratory (e.g., PK, ADA/immunogenicity, or PD/biomarker assays) in a regulated (GLP/GCLP/GxP) setting.\nExperience with GLP-regulated studies or regulated documentation practices is preferred.\nTechnical Skills\nFamiliarity with PK, PD, ADA, NAb, etc. bioanalytical workflows (e.g., ligand-binding assays, ELISA, multiplex immunoassays, molecular assays, or emerging biomarker platforms).\nExperience reviewing scientific reports, analytical datasets, and laboratory documentation.\nKnowledge of LIMS systems and electronic laboratory documentation practices.\nProficiency with Microsoft Excel, Word, and data formatting tools for dataset preparation.\nCore Competencies\nStrong attention to detail with a focus on data accuracy and data integrity.\nAbility to review complex datasets and identify inconsistencies.\nStrong written and verbal communication skills.\nAbility to manage multiple priorities in a fast-paced CRO environment.\nStrong collaboration skills when working with cross-functional teams.\nSalary and Benefits\nFrontage Laboratories offers a competitive compensation and benefits package including health and dental insurance, a 401(k) plan, disability insurance, and life insurance.\nFrontage Laboratories Inc. is an equal opportunity employer. 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