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Senior Quality Assurance Associate

eugia usHightstown, NJ

2 days ago

Occupations

Quality Control AnalystsQuality Control Systems ManagersInspectors, Testers, Sorters, Samplers, and Weighers

Industries

Pharmaceutical Preparation ManufacturingBiological Product ManufacturingDrugs and Druggists' Sundries Merchant Wholesalers

$27.00/Hr

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About the role

Senior Quality Assurance Associate As a Senior Quality Assurance Associate, you will provide strategic quality support to warehouse and distribution operations. This role ensures compliant receipt, inspection, and release of pharmaceuticals through adherence to GDP, DSCSA serialization requirements, and FDA import regulations. You will independently manage deviations and nonconformances, lead supplier quality assessments, drive CAPA closure and verification, maintain regulatory compliance documentation, and support Quality leadership on cross-functional initiatives and regulatory interactions.
Work Schedule: Monday through Friday, 10:30am to 7:30pmResponsibilitiesLead receipt and inspection of pharmaceutical products for compliance with GDP, DSCSA, and regulatory requirements. Verify DSCSA serialization, lot traceability, and chain of custody documentation. Identify and manage suspect or illegitimate product reports. Monitor warehouse environmental conditions and storage compliance. Inspect returned goods for disposition and regulatory compliance. Write, revise, and approve QA documentation (SOPs, procedures, work instructions).Investigate and resolve deviations and nonconformances. Execute QA review and approval of product release documentation. Support continuous improvement activities to enhance Quality operations and regulatory compliance.
Qualifications:
  • Skills & Requirements
  • Good knowledge of Microsoft Office applications.
  • Organizational and leadership skills.
  • Excellent data collection and analysis skills.
  • Keen attention to detail, and Critical/logical thinking
  • Strong knowledge of GMP regulations and their application.
  • Demonstrated ability to communicate technical information or complex situations to supervisor or area management in a concise and clear manner.
  • Excellent verbal, written, and teamwork communication skills.
Education & Experience: Minimum B.S. degree; preferably in a scientific field.2-3 years of experience in Quality Assurance or a similar field within the pharmaceutical industry. Oracle experience (preferred).
Benefits:
  • Medical and Rx Benefits choice of four medical plans through Horizon. Rx automatically provided with medical benefits
  • Dental Benefits with three dental plan options through CIGNAVision Plan with two plan options through VSPLife Insurance, Basic Life and AD&D and Supplemental Life Insurance
  • Disability Insurance, Voluntary Short-Term Disability and State Disability
  • Long-Term Disability (LTD), State (short term) disability – where applicableFSA (Flexible Spending Accounts) – Both Health Care & Dependent Care AvailableHSA (Health Savings Account)401(k) Plan - Through Fidelity / Employer Match / fully vested after 3 years
  • Employee Assistance Program (EAP) - 100% Confidential and 100% company paid
  • Critical Illness and Accidental Insurance
  • Legal and Identity Theft Insurance
Paid Time Off: Paid vacation, PTO, Holiday
Notice to Recruitment Agencies: Please note that we are not accepting unsolicited resumes or proposals from recruitment firms or agencies for this position. Thank you for your understanding.
Compensation: MinUSD $27.00/Hr. MaxUSD $29.00/Hr.
Physical Requirements: WAREHOUSE OR PRODUCTION POSITION – While performing the duties of this job the employee is required to: Regularly lift and/or move objects 10-50lbs Frequently required to stand, walk, stoop, kneel, crouch or crawl Occasionally required to sit and climb or balance Specific vision abilities required for this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust and focus The worker is subject to environmental conditions. Protection from weather conditions but not necessarily from temperature changes The worker is subject to both environmental conditions. Activities occur inside and outside Medium work Exerting up to 50 pounds of force occasionally, and/or up to 30 pounds of force frequently, and/or up to 10 pounds of force constantly to move objects. Additional Physical Requirements Blood/Fluid Exposure Risk Category III: Tasks involve no exposure to blood, body fluids or tissues. Category I tasks are not a condition of employment.

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JOB OVERVIEW

Salary

$27.00/Hr

Experience level

Senior

Location

Hightstown, NJ

Occupation

Quality Control Analysts

Industry

Pharmaceutical Preparation Manufacturing

Posted

2 days ago

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