4 дня назад
Manufacturing Compliance Specialist I/II (Swing Shift)
70 000 - 90 000$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Manufacturing Compliance Specialist I/II (Swing Shift) (Biopharmaceutical Manufacturing): Supporting compliant manufacturing operations on the floor through batch documentation review, ERP troubleshooting, material management, and cleanroom readiness with an accent on GMP quality systems and real-time operational guidance. Focus on maintaining manufacturing compliance, coordinating mitigation efforts with Manufacturing and QA, and mentoring floor staff during a Monday–Friday 2:00 PM–10:30 PM shift.
Location: Boulder, Colorado, United States; onsite work on the Manufacturing floor in a clean room environment. Schedule: Monday–Friday, 2:00 PM–10:30 PM.
Salary: $70,000–$90,000 per year.
Company
operates in biopharmaceutical manufacturing and develops and supports production processes for biologic products.
What you will do
- Provide real-time compliance guidance, training, and corrective support during manufacturing operations.
- Execute and review batch documentation and logbooks.
- Troubleshoot and reconcile ERP records and support material workflow management.
- Verify area readiness and cleanroom compliance standards.
- Collaborate with Manufacturing management, floor staff, and QA on process mitigation.
- Mentor manufacturing personnel in partnership with management and training specialists.
Requirements
- Bachelor’s degree in a related scientific discipline and 4 years of relevant cGMP manufacturing experience, or a high school diploma and 7 years of experience, or equivalent.
- Prior GMP operations experience and knowledge of quality systems and regulatory expectations.
- Strong organization and attention to detail in a fast-paced, multitasking environment.
- Ability to work hands-on in manufacturing and cleanroom operations.
- Knowledge of upstream microbial fermentation or downstream biopharmaceutical unit operations is preferred.
- Excellent written and verbal communication skills are preferred.
Nice to have
- Experience with single-use and stainless-steel platform technologies.
Culture & Benefits
- Cross-functional collaboration with Manufacturing, QA, floor staff, and training specialists.
- Hands-on work supporting site and department objectives.
- Full-time employment with a fixed Monday–Friday swing-shift schedule.
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