Operations Excellence Specialist
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This role is responsible for overseeing the daily operations of an external manufacturing site. The Operations Excellence Specialist will work closely with the joint process team to ensure compliance with global contract manufacturing standards.
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The ideal candidate will have a strong understanding of cGMPs and drug product manufacturing, as well as excellent communication and interpersonal skills. They will be able to represent the company's mission, policies, and practices in a positive and professional manner, and influence contract manufacturers to achieve operational excellence.
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Key Responsibilities:
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* Define and implement operational excellence roadmaps to improve safety, quality, and productivity
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* Invest time on the shop floor to ensure practices match local procedures and identify best practices
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* Establish and promote human error prevention programs, tracking metrics and overall performance
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* Transfer operational knowledge to contract manufacturers to minimize recurrent deviations and ensure flawless execution
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* Support ongoing contract manufacturer operations by providing operational oversight and facilitating communication between the joint process team and contract manufacturers
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* Become the primary contact person for the joint process team, supporting issue management and escalation
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* Contribute to identifying and implementing continuous improvement and operational excellence projects at the contract manufacturer
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* Manage conflict and problem resolution
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* Assist contract manufacturers in preparing for audits from regulatory agencies
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* Translate process requirements and educate joint process team members
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Requirements:
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* Bachelor's degree or equivalent work experience in a related field
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* Minimum of 3 years' experience in pharmaceutical manufacturing and/or operations
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* Strong communication and interpersonal skills
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* Ability to represent the company's mission, policies, and practices in a positive and professional manner
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* A thorough understanding of cGMPs and drug product manufacturing
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* Proven ability to organize and prioritize multiple tasks using a Lean Six-Sigma approach
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* Ability to work in a virtual and complex environment
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* Appreciation for cultural diversity
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* Willingness to travel
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Preferred Skills:
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* Knowledge and ability to apply basic statistical tools
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* Basic knowledge of common Lean Six-Sigma programs
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* Experience in continuous improvement and operational excellence processes
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* Prior experience supporting device assembly and packaging manufacturing
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About the Company:
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We are a global healthcare leader dedicated to helping individuals with disabilities engage in the workforce. We are committed to ensuring equal opportunities for all employees and strive to create a diverse and inclusive work environment.
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Working Conditions:
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This role requires frequent travel, up to 20% of the time. The shift is days, but off-hours may be necessary to support operations.