Hybrid in CO: Serialization SME (232126)

Life Sciences & Technology
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Job Description:

Our Pharmaceutical client is looking for a senior level Serialization consultant with at least 5-7 years of experience. This resource should have extensive experience with serialization, system configurations, quality and data management, and regulatory compliance in accordance with DSCSA guidelines. While there will be an aspect of project management in this role, this position is also going to be heavily hands on including operational execution of system release assessments, change controls, CAPAs, and technical troubleshooting. They are currently in the process of implementing ANTARES and are using RFxcel for data transferring. There will be 6-7 meetings on a weekly basis that this resource will be involved in which includes internal meetings, meetings with foreign partners, sitting in on meetings with cross functional teams, and ANTARES and RFXCEL teams, all while creating a maintenance plan along the way for the process to become sustainable.

Responsibilities:

• Support planning and coordinate implementation of Serialization alongside Project Management to reach Serialization requirements

• Work with contracted vendors to onboard customers for Serialization

• Work on integration of Serialization hardware and software including:

o Antares RFXCEL RTS, IRIS

o Optel

o Tracelink

o ERP (Deacom)

o Scanners, printers

• Develop and maintain KPIs, monitoring and reporting tools

• Governance of operational support model, including operational procedures, training curricula and user administration

• SME and decision maker for system specific topics such as system configuration, serialization data communication standards

• Step in for complex issues such as Exception investigations, strategic CAPAs

• Execute and support testing

• Develop and review validation documents and other project deliverables

• Complete necessary validation activities to ensure successful Production go-live

• Advise on and develop plan for consolidation and retirement of Serialization systems/ solution

Skills:

serialization, project management, operations

Education:

experience outweighs degree

Hybrid in CO: Serialization SME (232126)

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About Black Diamond Networks
Black Diamond Networks delivers talent uplifted. We deploy highly skilled consultants to support quality, compliance, and innovation in regulated industries and beyond. Black Diamond’s delivery model is wired for speed and precision, due to a cultivated community of experts in life sciences, engineering, and technology. Raise your expectations for dynamic solutions.

Black Diamond Networks is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

Start Date
ASAP
State
Colorado
(Remote)

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