Quality Assurance Stability Associate

Englewood Lab; Totowa (NJ); In loco; USD 48.712.000 - 60.174.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical, Dental & Vision Insurance

401(k) with Company Match

Paid Time Off (PTO)

Paid Company Holidays

Special Paid Leave for Personal Events

Descrizione del lavoro

Englewood Lab is seeking a QA Associate – Stability to support the OTC drug stability program onsite in Totowa, NJ. You will maintain the stability schedule, coordinate sample storage, pulls, and shipments to internal and external labs, and assist with stability protocols and reports.

The role requires an Associate's degree in a scientific discipline, 0–2 years in QA, QC, or GMP environments, familiarity with cGMP and ISO 22716, and strong attention to data integrity, documentation, and

Competenze

• Associate's degree in a scientific discipline or equivalent mix of education and experience.
• 0–2 years in QA, QC, stability, or GMP-regulated lab operations; OTC/pharma preferred.
• Knowledge of cGMP (21 CFR 210/211) and ISO 22716; ICH stability guidelines a plus.
• Strong attention to detail, organization, and cross-functional collaboration.

Mansioni

• Maintain stability program calendar, sample pulls, and storage coordination.
• Support stability chamber monitoring, excursions, and documentation.
• Review stability data for accuracy and trends in accordance with protocols.
• Assist investigations into stability deviations and OOS/OOT results.
• Ensure stability records meet data integrity standards and audit readiness.
• Support change control and documentation за stability processes.

Conoscenze

Attention to detail

Written communication

Verbal communication

Analytical skills

Organization

Cross-functional collaboration

Formazione

Associate's degree in scientific discipline

Strumenti

Excel

Word

PowerPoint

Descrizione del lavoro

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 window
• Support new study setup, including labeling, sample quantity checks, storage location assignment and creating study records under approved protocols
• Maintain a tracker of active studies, pending pulls, testing status and reports due, and elevate at-risk or missed pull points
• Coordinate 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 labs
• Maintain accurate sample inventory, including reconciliation and disposal of expired or completed study samples
• Support daily chamber oversight: review temperature and humidity monitoring records, document alarms and excursions, and coordinate with Facilities and Engineering on chamber issues
• Help document and assess the impact of chamber excursions and out-of-condition storage events, and track related corrective actions to closure
• Track 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 points
• Enter, 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 results
• Help prepare stability summary reports, shelf-life and expiration dating support, and customer stability data packages
• Support drafting and revision of stability protocols, amendments and study summaries
• Prepare stability metrics and status updates (e.g., on-time pull rate, testing turnaround, open investigations)

Investigations & Compliance Support

• Flag potential OOS, OOT or unexpected results to the Stability Coordinator and QA, and support initial data gathering
• Help document stability-related deviations, NCRs and QIRs by gathering records, sample history and batch information for QA- and QC-led investigations
• Track stability-related deviations and CAPAs and follow up with owners to help ensure timely closure and effectiveness checks
• Support change control for changes to formulation, packaging, suppliers or storage conditions by helping assess and document their impact on studies
• Keep 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 data
• Support periodic review of stability-related electronic records and audit trails (e.g., ERP, instrument software, monitoring systems), and elevate anomalies
• File, scan and archive stability documentation according to record retention requirements
• Help write and revise stability SOPs, work instructions and forms

General

• Suggest ways to improve stability program efficiency, tracking tools and documentation
• Perform 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 experience
• 0–2 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 plus
• Basic 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 plus
• Familiarity with good documentation practices and data integrity principles (ALCOA+)
• Exposure to stability chambers, environmental monitoring systems or sample chain of custody is preferred
• Strong attention to detail and organization, with the ability to manage recurring deadlines across multiple studies
• Good analytical skills, including the ability to trend numerical data and recognize out-of-range results
• Good written and verbal communication skills, and the ability to work with QC, Manufacturing, R&D and external labs
• Proficiency in Word, Excel and PowerPoint. ERP or LIMS experience is a plus
• Ability to lift and handle stability samples and work in controlled storage areas as needed

Work Schedule

• Onsite position based in Totowa, New Jersey
• Monday through Friday, full-time
• Overtime 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 Insurance
• Company-paid Life, AD&D and Disability Insurance
• 401(k) with Company Match
• Paid Time Off (PTO)
• Paid Company Holidays
• Special Paid Leave for Personal Events
• Employee Referral Program
• Year-End Gift
• Additional 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.