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The Steely Group
http://www.thesteelygroup.com
http://www.thesteelygroup.com
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Sr. Operations Specialist
Posted: 02/13/2025
2025-02-13
2025-03-21
Employment Type:
Direct Hire
Job Category: Scientific
Job Number: 4237
Job Description
We are seeking a highly skilled and motivated Operations Specialist to join the Operations Team.
You will have opportunities to participate in various projects and initiatives in addition to these primary responsibilities:
Responsibilities
Requirements:
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.
- Experience in new process implementation and continuous improvement
- Help draft technical documentation for drug product and drug substance manufacturing.
- Assist the Operations team with environmental monitoring, cleaning programs, and inventory management.
- Experience leading Operations projects
- 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:
- 8-10 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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