обновлено 10 дней назад
Operations Production Specialist (Biotechnology)
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Operations Production Specialist (Biotechnology): Ensuring manufacturing operations run safely, efficiently, and in compliance with GMP standards with an accent on production documentation, data integrity, and GMP compliance. Focus on managing batch records, leading continuous improvement initiatives, and partnering with Quality and MSAT teams to deliver life-changing therapies.
Location: Fully site-based in Bend, Oregon, USA. Relocation assistance available for eligible candidates.
Company
A global leader in life sciences operating across five continents, dedicated to manufacturing breakthrough medicines.
What you will do
- Manage batch records, forms, logbooks, and other controlled manufacturing documents.
- Prepare, review, and issue production documentation to support manufacturing readiness.
- Review completed batch records and electronic data to ensure accuracy, completeness, and data integrity.
- Support GMP compliance activities, investigations, corrective actions, and process changes.
- Maintain inspection readiness and support internal and external audits.
- Lead continuous improvement and Lean manufacturing initiatives in collaboration with Operations, Quality, and MSAT.
Requirements
- High School Diploma or GED.
- Experience in a GMP-regulated manufacturing environment (biotechnology, pharmaceutical, or medical device).
- Knowledge of Good Documentation Practices and data integrity principles.
- Experience supporting quality systems, investigations, or compliance activities.
- Strong communication, collaboration, and problem-solving skills.
Nice to have
- Familiarity with project management tools.
- Knowledge of continuous improvement methodologies.
Culture & Benefits
- Medical, dental, and vision insurance.
- Compensation programs that recognize high performance.
- Inclusive and ethical workplace with an agile career culture.
- Opportunities to lead continuous improvement initiatives.
- Exposure to cross-functional teams across Operations, Quality, and MSAT.
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