Our client is seeking a highly skilled and motivated Operations Specialist to support their 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:

• Support the Operations team in drug substance and/or drug product manufacturing.
• Help draft technical documentation for drug product 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:

• Minimum of 5 years of experience working in manufacturing or laboratory operations required.
• Ability to work in a clean room environment is required.
• Pharmaceutical or Medical Device industry experience is preferred.
• Knowledge of FDA, cGMP, and ICH regulatory requirements is preferred.
• 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.