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The Steely Group
http://www.thesteelygroup.com
http://www.thesteelygroup.com
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Operations Specialist
Posted: 04/15/2025
2025-04-15
2025-05-20
Employment Type:
Direct Hire
Job Category: GMP/cGMP
Job Number: 4372
Job Description
In this role, you will be responsible for supporting the Operations team by implementing and executing manufacturing processes in a regulated, controlled environment.
You will have opportunities to participate in various projects and initiatives in addition to these primary responsibilities:
Responsibilities:
Requirements / Qualifications:
You will have opportunities to participate in various projects and initiatives in addition to these primary responsibilities:
Responsibilities:
- Support the Operations team in drug substance and/or drug product manufacturing.
- Help draft technical documentation for drug product and drug substance manufacturing.
- Assist the Operations team with environmental monitoring, cleaning programs, and inventory management.
- Maintain manufacturing areas and process components to ensure a clean, safe and organized work environment.
- Work collaboratively with and support the Development Lab and Quality teams.
- Follow standard operation procedures (SOP) and work instructions to execute tasks.
Requirements / Qualifications:
- Bachelor’s degree required
- Minimum 5 years working in manufacturing or laboratory operations is required.
- Able to work in a clean room environment environment is required.
- Pharmaceutical or Medical Device industry experience is required.
- Knowledge of FDA, cGMP, and ICH regulatory requirements is required.
- Must be well organized, attentive to detail and have effective verbal and written communication skills.
- Must be able to efficiently prioritize, manage and complete multiple projects and tasks in a fast-paced environment.
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