Quality Assurance Stability Associate

Quality Assurance - Stability Associate Quality Assurance Associate – Stability Location: Totowa, NJ (Onsite) Employment Type: Full-Time | Non-Exempt (Hourly) Department: Quality Assurance Reports To: QA-OTC Drug Stability Coordinator Organizational Relationships: Works closely with the QA-OTC Drug Stability Coordinator and the Drug Stability Technician. Works with QA Systems & Compliance, QA Documentation, Validation, QC, Manufacturing, R&D, Process Engineering, Warehouse, Regulatory Affairs, Purchasing, external contract testing laboratories, and customer quality contacts as needed to support the stability program. Position Summary The QA Associate – Stability gives day-to-day quality assurance support to the QA-OTC Drug Stability Coordinator in running the site's OTC drug stability program, working alongside the Drug Stability Technician. You will maintain the stability schedule and pull calendar, coordinate sample storage, pulls and shipments to internal and external labs, support stability chamber monitoring and excursion documentation, and review and trend stability data. You will also help with stability protocols and reports, support investigations into stability-related deviations and OOS/OOT results, and keep stability records complete and accurate. All work follows cGMP (21 CFR 210/211, including 211.166 and 211.137), ISO 22716, ICH stability principles and customer requirements, with a strong commitment to data integrity. Responsibilities Stability Program Coordination Help maintain the master stability schedule, tracking study start dates, storage conditions and upcoming pull points (e.g., initial, 1, 2, 3, 6, 9, 12, 18, 24 and 36 months)Prepare and issue pull notices and work orders to QC and contract labs ahead of each pull date, and confirm pulls are completed within the allowable windowSupport new study setup, including labeling, sample quantity checks, storage location assignment and creating study records under approved protocolsMaintain a tracker of active studies, pending pulls, testing status and reports due, and escalate at-risk or missed pull pointsCoordinate with the Drug Stability Technician, Manufacturing, R&D and Regulatory Affairs on batch selection, packaging configurations and study requirements for commercial, new product and change-related studies Sample Management & Chamber Support Perform and document stability sample pulls, chain of custody and shipments to internal and external labsMaintain accurate sample inventory, including reconciliation and disposal of expired or completed study samplesSupport daily chamber oversight: review temperature and humidity monitoring records, document alarms and excursions, and coordinate with Facilities and Engineering on chamber issuesHelp document and assess the impact of chamber excursions and out-of-condition storage events, and track related corrective actions to closureTrack chamber qualification, mapping and calibration due dates and maintain the related records Stability Data Review & Reporting Review stability results from QC and contract labs for completeness, accuracy and conformance to protocol specifications and time pointsEnter, verify and trend stability data (e.g., assay, pH, viscosity, appearance, micro and preservative efficacy) in Excel or approved systems to spot shifts, trends and potential OOT resultsHelp prepare stability summary reports, shelf-life and expiration dating support, and customer stability data packagesSupport drafting and revision of stability protocols, amendments and study summariesPrepare stability metrics and status updates (e.g., on-time pull rate, testing turnaround, open investigations) for QA leadership Investigations & Compliance Support Flag potential OOS, OOT or unexpected results to the Stability Coordinator and QA, and support initial data gatheringHelp document stability-related deviations, NCRs and QIRs by gathering records, sample history and batch information for QA- and QC-led investigationsTrack stability-related deviations and CAPAs and follow up with owners to help ensure timely closure and effectiveness checksSupport change control for changes to formulation, packaging, suppliers or storage conditions by helping assess and document their impact on studiesKeep stability records audit-ready and help with document and sample requests during customer audits and regulatory inspections Data Integrity & Documentation Apply GDP and ALCOA+ principles to all stability records, including logbooks, pull records and electronic dataSupport periodic review of stability-related electronic records and audit trails (e.g., ERP, instrument software, monitoring systems), and escalate anomaliesFile, scan and archive stability documentation according to record retention requirementsHelp write and revise stability SOPs, work instructions and forms General Suggest ways to improve stability program efficiency, tracking tools and documentationPerform other assignments as directed by the QA-OTC Drug Stability Coordinator, QA Systems & Compliance Lead or Director of Quality Assurance Qualifications Associate's degree in a scientific discipline (e.g., chemistry, biology, pharmaceutical science or a related field), or an equivalent mix of education and experience0–2 years of experience in QA, QC, stability or lab operations in a GMP-regulated environment. Internship or co-op experience counts. OTC drug or pharmaceutical experience is preferred, and cosmetic experience is a plusBasic knowledge of cGMP (21 CFR 210/211) and ISO 22716. Familiarity with ICH stability guidelines (e.g., Q1A(R2)) and stability study design is a plusFamiliarity with good documentation practices and data integrity principles (ALCOA+)Exposure to stability chambers, environmental monitoring systems or sample chain of custody is preferredStrong attention to detail and organization, with the ability to manage recurring deadlines across multiple studiesGood analytical skills, including the ability to trend numerical data and recognize out-of-range resultsGood written and verbal communication skills, and the ability to work with QC, Manufacturing, R&D and external labsProficiency in Word, Excel and PowerPoint. ERP or LIMS experience is a plusAbility to lift and handle stability samples and work in controlled storage areas as needed Work Schedule Onsite position based in Totowa, New JerseyMonday through Friday, full-timeOvertime may be required to support audits, inspections, regulatory submissions and business needs. Overtime is paid in accordance with applicable federal and New Jersey law Compensation $17.00 – $21.00 per hour Actual pay will be based on experience, qualifications, skills and internal equity. Benefits Medical, Dental & Vision InsuranceCompany-paid Life, AD&D and Disability Insurance401(k) with Company MatchPaid Time Off (PTO)Paid Company HolidaysSpecial Paid Leave for Personal EventsEmployee Referral ProgramYear-End GiftAdditional benefits as outlined in the Employee Handbook Equal Opportunity Employer Englewood Lab, Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, pregnancy, veteran status, or any other characteristic protected by applicable federal, state, or local law. Englewood Lab provides reasonable accommodations to qualified individuals with disabilities in accordance with applicable law. Powered by JazzHR XX8w6FPbGj