{"id":1684156,"url":"https://alion.io/job/abzena-qc-associate-iii-contract","title":"QC Associate I/II - Contract","company":{"id":2138905,"name":"Abzena","domain":"abzena.com","url":"https://alion.io/company/abzena","size_band":null,"is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Lever","truth_index":{"grade":"B","score":75,"open_postings":4,"ghost_share":0,"stale_share":1,"repost_share":0,"time_to_fill_p50_days":null,"computed_at":"2026-10-07T05:47:15Z"}},"role":"Science & Research","role_family":"Science & Research","seniority":"middle","employment_type":"contractor","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["San Diego, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":40,"max":60,"currency":"USD","period":"hour","gross":null,"usd_annual":120000},"salary_estimate":null,"experience_years_min":3,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-09-29T13:12:19Z","employer_posted_date":"2026-09-29","last_verified_at":"2026-10-08T01:05:13Z","board_verified":true,"closed_at":null,"days_open":8,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":8},"description":"The Quality Control (QC) Associate I / II is responsible for performing analytical testing and laboratory activities that support stability, qualification/validation, and supporting release testing of biologics in a cGMP-regulated environment. This role supports routine QC operations through the execution of analytical methods, data review, laboratory investigations, method transfer activities, equipment maintenance, and continuous improvement initiatives while ensuring compliance with current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), and applicable regulatory requirements.\nThe successful candidate will demonstrate strong technical expertise, attention to detail, data integrity awareness, and a commitment to maintaining inspection readiness while supporting internal and client-driven programs.\nResponsibilities\nAnalytical Testing and Laboratory Operations\nPerform routine and non-routine analytical testing of in-process, release, stability, characterization, reference standard, raw material, and investigational samples using approved methods and procedures.\nExecute a variety of analytical techniques commonly used for biologics and large-molecule products, including but not limited to:HPLC/UHPLC\nCE-SDS\ncIEF/icIEF\nELISA\nUV-Vis Spectroscopy\nCompendial testing\nOther biochemical and physicochemical methods as applicable.\nEnsure all testing activities are completed accurately, efficiently, and within established timelines.\nMaintain laboratory notebooks, worksheets, logbooks, and electronic records in accordance with GDP and ALCOA+ data integrity principles.\nEnsure all activities comply with GMP, ALCOA+ principles, and data integrity regulations (FDA, EMA, ICH guidelines).\nReview and support validation documentation, test scripts, and execution records. LIMS knowledge is a plus.\nIdentify and escalate compliance risks during system transition.\nSupport analytical method transfer, qualification, verification, and validation activities from Analytical Development or external clients into GMP QC laboratories.\nOther Lab Responsibilities/Skills\nParticipate in comparability, bridging, and lifecycle management activities for analytical methods and reference standards.\nPerform first-person review of analytical data to ensure completeness, accuracy, and compliance with applicable procedures and regulatory requirements.\nAssist in the preparation and review of: Certificates of Analysis (CoA), Stability Summary Sheets (SSS), Analytical reports, Method qualification and validation reports, technical memoranda and laboratory documentation. Ensure documentation is complete, contemporaneous, attributable, and inspection ready.\nParticipate in laboratory investigations involving: OOS, OOT, invalids, and other lab investigations as needed.\nMaintain laboratory equipment records and ensure equipment remains in a qualified state.\nSupport laboratory readiness for internal audits, client audits, regulatory inspections, and quality assessments.\nParticipate in process improvement initiatives to enhance laboratory efficiency, compliance, and data integrity.\nCollaborate effectively with cross-functional teams including QA, AMD, Manufacturing, MSAT, and Materials Management.\nSupport implementation of new technologies, systems, and laboratory processes.\n\nQualifications\nRequired Qualifications and Skills:\nBachelor’s degree in chemistry, Biochemistry, Pharmaceutical Sciences, or related scientific field.\n\n3-7+ years of experience in GMP Quality Control laboratory environment.\n\nHands-on experience with HPLC/UPLC systems and chromatography data systems.\n\nDirect experience with either Empower CDS or LIMS implementation preferred.\n\nStrong understanding of GMP regulations and data integrity expectations.\n\nPreferred Skills & Experience:\nPrior experience transitioning from OpenLab, ChemStation, or similar CDS to Empower.\n\nExposure to LIMS configuration or implementation projects.\n\nExperience supporting CSV (Computer System Validation) activities.\n\nStrong problem-solving and troubleshooting skills in analytical environments.\n\nAbility to work independently in a fast-paced project environment.\n\nWorking Conditions & Physical Demands\nEnvironment: GMP-regulated Quality Control laboratory.\nChemical Exposure: Frequent handling of organic solvents, acids, buffers, and standards (e.g., methanol, acetone, IPA, acetonitrile).\nHazard Exposure: Potential contact with materials classified as corrosive, flammable, toxic, carcinogenic, or reproductive hazards (e.g., boric acid, β-mercaptoethanol, sulfuric acid, silver nitrate).\nSafety Protocols: Strict adherence to the Chemical Hygiene Plan, SOPs, and Safety Data Sheet (SDS) instructions is required.\nPPE Requirements: Mandatory use of lab coats, nitrile gloves, and safety glasses. Tasks may require face shields, splash goggles, or respiratory protection.\nDaily Activities: Frequent pipetting, weighing, reagent preparation, and instrument operation. Handling of hazardous materials occurs inside laboratory hoods.\nPhysical Effort: Regular sitting, standing, walking, bending, reaching, and repetitive hand movements.\nLifting: Ability to occasionally lift and transport laboratory supplies up to 25 pounds.\n We are committed to providing an inclusive and accessible workplace. The essential functions of this role can be performed with or without reasonable accommodation. If you require an accommodation during the application process or to perform the job, please contact Human Resources.","description_format":"text","description_chars":5494,"description_truncated":false,"requirements":{"experience_years_min":3,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Biotechnology"],"lifecycle":[{"event":"open","at":"2026-10-02T10:02:46Z"}],"visa":[],"liveness":{"score":86,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.915,"p_room":0.945,"age_days":7,"expected_fill_days":18,"reasons":["conf:1","urgency","win:mid"],"computed_at":"2026-10-07T05:47:15Z"},"pay":{"stated_usd_annual":120000,"is_top_pay":true},"html_url":"https://alion.io/job/abzena-qc-associate-iii-contract","json_url":"https://alion.io/job/abzena-qc-associate-iii-contract.json","meta":{"generated_at":"2026-10-08T01:23:11Z","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","counted_by":"address","units_charged":1,"used_today":2476,"day_limit":5000,"remaining_today":2524,"minute_limit":60,"resets_at":"2026-10-09T00:00:00Z"}},"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":2138905},"rest":"https://alion.io/mcp/rest/get_company?id=2138905"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fabzena-qc-associate-iii-contract"},{"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%2Fabzena-qc-associate-iii-contract"},{"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%2Fabzena-qc-associate-iii-contract"},{"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/abzena-qc-associate-iii-contract\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fabzena-qc-associate-iii-contract"}]}