{"schemaVersion":"jobsearcher.job.v1","id":"ca0222a13a653e8e2a9f94f0","url":"https://jobsearcher.com/jobs/ca0222a13a653e8e2a9f94f0","canonicalUrl":"https://jobsearcher.com/jobs/ca0222a13a653e8e2a9f94f0","title":"Quality Associate","description":"COMPANY OVERVIEW\nHalo Pharmaceutical is a technology-focused contract manufacturing business with differentiated applications and capabilities in solid, semi-solid and liquid dosage forms, with a particular focus on controlled substances. Halo has long-standing commercial relationships with a number of major pharmaceutical companies and maintains facilities in both the United States and Canada.\nOur family of companies offers complete CDMO services including custom synthesis of intermediates, reference standards, drug substances and drug product manufacturing. Halo Pharma is part of Noramco. We are stronger together!\nOVERVIEW\nThe Quality Assurance Associate (temporary) will provide direct support for a newly launched product manufactured and stick-packed at the site, with a strong focus on shop floor presence and real-time quality oversight. This role is responsible for ensuring daily manufacturing and packaging activities are executed in compliance with cGMPs, approved procedures, and quality standards. Key responsibilities include performing line clearance and in-process checks, supporting batch record review (BRR), managing in-process sampling and testing oversight, and serving as the primary QA point of contact during operations. The associate will triage and support investigations, drive timely CAPA closure and effectiveness, and contribute to continuous improvement of batch records and documentation practices. In addition, the role ensures adherence to QMS processes, verifies material reconciliation and labeling accuracy, and collaborates cross-functionally with Manufacturing, Packaging, and QC teams to maintain compliance, inspection readiness, and a strong quality culture. This position is 100% on site in Whippany, NJ.\nRESPONSIBILITIES\nQA Inspection\nProvide on-the-floor QA oversight for daily manufacturing and packaging operations ensuring adherence to cGMPs and approved procedures.\nPerform line clearance activities and reviews before and after manufacturing/packaging runs, verifying equipment cleanliness, material status, and absence of mix-up risks.\nConduct in-process line checks and periodic walkthroughs to confirm compliance with batch records, SOPs, and GMP requirements.\nReview/approve batch records, protocols, and reports for accuracy, completeness and to identify any potential issues. Track, monitor and coordinate batch record lifecycle within Quality system.\nPerform real-time review of batch record entries and execution related supplemental/supporting documents such as logbooks, protocols, and other batch release documents\nPerform sampling of raw materials, packaging components and printed material following Halo SOP, ANSI, CFR, EHS and PMDA guidelines.\nManage and coordinate in-process (IP) & additional sampling activities, including sample collection, labeling, and submission to QC. Review of C of A or C of C, verify shipments and notify management for discrepancies.\nProvide quality support for on-floor process performance & validation execution and related activity.\nAct as QA point of contact during shop floor execution, providing immediate guidance on deviations, documentation errors, and procedural clarifications.\nEnsure compliance with Quality Management System (QMS) processes, including authoring and reviewing SOPs, deviations, CAPAs, change controls, and document management.\nIdentify and drive batch record and documentation improvements to enhance clarity, compliance, and right-first-time execution.\nTriage and support investigations (deviations, OOS/OOT), ensuring timely initiation, accurate documentation, and appropriate escalation.\nTrack CAPAs to ensure on-time closure and support effectiveness checks to confirm sustainable resolution of operation issues.\nVerify and maintain compliance over material movement within Quality department through SAP.\nCollaborate closely with Manufacturing, Packaging, and QC teams to support efficient operations while maintaining quality standards.\nSupport inspection readiness by maintaining accurate, complete, and audit-ready documentation at all times.\nPromote a strong quality culture by reinforcing GMP behaviors and providing real-time coaching to shop floor personnel.\nPOSITION QUALIFICATIONS\n· Working knowledge of cGMP regulations and guidelines (e.g., FDA, ICH) with practical application in manufacturing and packaging operations.\n· Experience performing line clearance, in-process checks, and real-time batch record review in a production environment.\n· Familiarity with Batch Record Review (BRR) processes and good documentation practices (GDP).\n· Hands-on experience with in-process sampling and/or in-process testing (IPT) coordination or oversight.\n· Experience supporting investigations (deviations, OOS/OOT), including documentation, root cause analysis, and follow-up actions.\n· Understanding of CAPA and change control processes within a Quality Management System (QMS), including tracking to closure and effectiveness checks.\n· Ability to work on the shop floor for extended periods and support a fast-paced manufacturing/packaging environment.\n· Strong attention to detail with the ability to identify compliance risks and drive right-first-time execution.\n· Effective communication and interpersonal skills, with the ability to collaborate cross-functionally and provide real-time QA guidance to operations teams.\n· Strong organizational and time management skills, with the ability to prioritize multiple tasks and meet deadlines.\n· Proficiency in standard office software (e.g., Microsoft Office) and familiarity with electronic quality systems (e.g., eQMS, MES) is a plus.\n· Flexibility to support non-standard hours, including shift or weekend coverage, as needed.\nEDUCATION:\n· Bachelor’s degree in scientific discipline (e.g., Chemistry, Biology, Pharmaceutical Sciences) or equivalent combination of education and relevant experience.\nEXPERIENCE:\n· 3+ years of experience in a GMP-regulated pharmaceutical, biotechnology, or related manufacturing environment; direct QA shop floor support experience preferred.\nHalo Pharma provides a pay range for this role in accordance with applicable pay transparency laws. Individual pay rates are determined by assessing expertise, skills, education, and professional background\nHalo is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.\nJob Type: Temporary\nPay: $32.00 per hour\nWork Location: In person","company":"Interactengineeringll","rawCompany":"interactengineeringll","city":"Morris Twp","state":"NJ","isRemote":false,"isActive":false,"createdAt":"2026-07-19T14:00:55.574Z","occupations":[{"code":"19-4099.01","title":"Quality Control Analysts","slug":"quality-control-analysts"},{"code":"11-3051.01","title":"Quality Control Systems Managers","slug":"quality-control-systems-managers"},{"code":"51-9061.00","title":"Inspectors, Testers, Sorters, Samplers, and Weighers","slug":"inspectors-testers-sorters-samplers-and-weighers"}],"industries":[{"code":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"},{"code":"325414","title":"Biological Product (except Diagnostic) Manufacturing","slug":"biological-product-except-diagnostic-manufacturing"},{"code":"325413","title":"In-Vitro Diagnostic Substance Manufacturing","slug":"in-vitro-diagnostic-substance-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Quality Associate","description":"COMPANY OVERVIEW\nHalo Pharmaceutical is a technology-focused contract manufacturing business with differentiated applications and capabilities in solid, semi-solid and liquid dosage forms, with a particular focus on controlled substances. Halo has long-standing commercial relationships with a number of major pharmaceutical companies and maintains facilities in both the United States and Canada.\nOur family of companies offers complete CDMO services including custom synthesis of intermediates, reference standards, drug substances and drug product manufacturing. Halo Pharma is part of Noramco. We are stronger together!\nOVERVIEW\nThe Quality Assurance Associate (temporary) will provide direct support for a newly launched product manufactured and stick-packed at the site, with a strong focus on shop floor presence and real-time quality oversight. This role is responsible for ensuring daily manufacturing and packaging activities are executed in compliance with cGMPs, approved procedures, and quality standards. Key responsibilities include performing line clearance and in-process checks, supporting batch record review (BRR), managing in-process sampling and testing oversight, and serving as the primary QA point of contact during operations. The associate will triage and support investigations, drive timely CAPA closure and effectiveness, and contribute to continuous improvement of batch records and documentation practices. In addition, the role ensures adherence to QMS processes, verifies material reconciliation and labeling accuracy, and collaborates cross-functionally with Manufacturing, Packaging, and QC teams to maintain compliance, inspection readiness, and a strong quality culture. This position is 100% on site in Whippany, NJ.\nRESPONSIBILITIES\nQA Inspection\nProvide on-the-floor QA oversight for daily manufacturing and packaging operations ensuring adherence to cGMPs and approved procedures.\nPerform line clearance activities and reviews before and after manufacturing/packaging runs, verifying equipment cleanliness, material status, and absence of mix-up risks.\nConduct in-process line checks and periodic walkthroughs to confirm compliance with batch records, SOPs, and GMP requirements.\nReview/approve batch records, protocols, and reports for accuracy, completeness and to identify any potential issues. Track, monitor and coordinate batch record lifecycle within Quality system.\nPerform real-time review of batch record entries and execution related supplemental/supporting documents such as logbooks, protocols, and other batch release documents\nPerform sampling of raw materials, packaging components and printed material following Halo SOP, ANSI, CFR, EHS and PMDA guidelines.\nManage and coordinate in-process (IP) & additional sampling activities, including sample collection, labeling, and submission to QC. Review of C of A or C of C, verify shipments and notify management for discrepancies.\nProvide quality support for on-floor process performance & validation execution and related activity.\nAct as QA point of contact during shop floor execution, providing immediate guidance on deviations, documentation errors, and procedural clarifications.\nEnsure compliance with Quality Management System (QMS) processes, including authoring and reviewing SOPs, deviations, CAPAs, change controls, and document management.\nIdentify and drive batch record and documentation improvements to enhance clarity, compliance, and right-first-time execution.\nTriage and support investigations (deviations, OOS/OOT), ensuring timely initiation, accurate documentation, and appropriate escalation.\nTrack CAPAs to ensure on-time closure and support effectiveness checks to confirm sustainable resolution of operation issues.\nVerify and maintain compliance over material movement within Quality department through SAP.\nCollaborate closely with Manufacturing, Packaging, and QC teams to support efficient operations while maintaining quality standards.\nSupport inspection readiness by maintaining accurate, complete, and audit-ready documentation at all times.\nPromote a strong quality culture by reinforcing GMP behaviors and providing real-time coaching to shop floor personnel.\nPOSITION QUALIFICATIONS\n· Working knowledge of cGMP regulations and guidelines (e.g., FDA, ICH) with practical application in manufacturing and packaging operations.\n· Experience performing line clearance, in-process checks, and real-time batch record review in a production environment.\n· Familiarity with Batch Record Review (BRR) processes and good documentation practices (GDP).\n· Hands-on experience with in-process sampling and/or in-process testing (IPT) coordination or oversight.\n· Experience supporting investigations (deviations, OOS/OOT), including documentation, root cause analysis, and follow-up actions.\n· Understanding of CAPA and change control processes within a Quality Management System (QMS), including tracking to closure and effectiveness checks.\n· Ability to work on the shop floor for extended periods and support a fast-paced manufacturing/packaging environment.\n· Strong attention to detail with the ability to identify compliance risks and drive right-first-time execution.\n· Effective communication and interpersonal skills, with the ability to collaborate cross-functionally and provide real-time QA guidance to operations teams.\n· Strong organizational and time management skills, with the ability to prioritize multiple tasks and meet deadlines.\n· Proficiency in standard office software (e.g., Microsoft Office) and familiarity with electronic quality systems (e.g., eQMS, MES) is a plus.\n· Flexibility to support non-standard hours, including shift or weekend coverage, as needed.\nEDUCATION:\n· Bachelor’s degree in scientific discipline (e.g., Chemistry, Biology, Pharmaceutical Sciences) or equivalent combination of education and relevant experience.\nEXPERIENCE:\n· 3+ years of experience in a GMP-regulated pharmaceutical, biotechnology, or related manufacturing environment; direct QA shop floor support experience preferred.\nHalo Pharma provides a pay range for this role in accordance with applicable pay transparency laws. Individual pay rates are determined by assessing expertise, skills, education, and professional background\nHalo is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.\nJob Type: Temporary\nPay: $32.00 per hour\nWork Location: In person","datePosted":"2026-07-19T14:00:55.574Z","dateModified":"2026-07-19T14:00:55.574Z","hiringOrganization":{"@type":"Organization","name":"Interactengineeringll","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Morris Twp","addressRegion":"NJ","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"ca0222a13a653e8e2a9f94f0"},"url":"https://jobsearcher.com/jobs/ca0222a13a653e8e2a9f94f0"}}