9 часов назад
MQA Specialist - 2nd Shift
60 966 - 85 000$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
MQA Specialist - 2nd Shift (GMP Quality Assurance): Providing quality oversight for pharmaceutical production processes, laboratories, documentation, and finished-product storage with an accent on shop-floor compliance, deviation management, and aseptic manufacturing controls. Focus on investigating quality issues, proposing CAPAs, monitoring production activities, and ensuring adherence to FDA, GMP, and company procedures.
Location: Grand Island, New York, United States; on-site, 2:00 PM–10:30 PM Monday through Friday
Salary: $60,966–$85,000 per year
Company
provides healthcare products and operates regulated pharmaceutical production facilities.
What you will do
- Provide quality oversight across production, support processes, laboratories, warehousing, storage, facilities, and utilities.
- Verify weighing and dispensing, component preparation, in-process controls, filling, lyophilization, finishing, packaging, and visual inspection activities.
- Identify critical deviations, stop production when necessary, contain affected materials or products, and escalate systemic issues to site management.
- Support investigations, root-cause analyses, corrective and preventive actions, validation studies, media fills, repackaging, and reworking.
- Review master batch records and logbooks for GMP and procedural compliance and provide real-time shop-floor documentation support.
- Drive continuous quality improvement and participate in 5S and other compliance projects.
Requirements
- High school diploma and 1–3 years of relevant work experience.
- Associate degree or experience in a GMP-regulated industry is preferred.
- Knowledge of regulatory requirements, industry best practices, and production technologies.
- Competence with computerized systems; Word, Access, and Excel knowledge is a plus.
- Strong organization, troubleshooting, stress resilience, personal integrity, and relevant production experience.
Culture & Benefits
- Continuous quality improvement culture with an active shop-floor presence.
- Medical, prescription drug, dental, and vision coverage.
- 401(k) plan with company contributions, life insurance, disability coverage, and wellness benefits.
- Paid vacation, holidays, personal days, and an employee assistance program.
- Employment is at-will and subject to applicable federal and state laws.
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