Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

Responsibilities:

• Successful completion of Quality initiatives by supporting assigned strategic projects.
• Development of training tools / job aids / work instructions on an "as needed" basis to support ongoing business needs.
• Lead in supporting PPI initiatives/goals.
• Perform audit functions as described by SOP Procedures.
• Involvement in the rollout of systems to the site, including developing associated documentation and processes for users.
• Serve as a dedicated SME for SampleManager LIMS, heavily involved in system processes and changes.
• Engage in activities to support SampleManager LIMS, including resolving issues during system implementation and maintaining and solving problems with current systems.
• Build business and customer relationships, comprehend global business processes, and aid in project charters, test plans, and requirements specifications in a GXP environment. Support the completion of test plans.
• Interact with service delivery and solutions delivery teams to understand reported issues and the operations of the systems.
• Apply full development lifecycle methodology, including requirements gathering and process mapping, ensuring the delivered solution meets requirements.
• Evaluate information from different sources, reconcile conflicts, and distinguish user requests from underlying true needs.
• Resolve conflicts and differentiate between business and technical requirements. Advance system issues, when vital, to the designated ETO/IT Team.
• Consistently apply a consultative approach with customers to understand their strategy.
• Write clearly and succinctly in various communication tools (memos, presentations, reports, etc.), delivering complex messages in a simple, easy-to-understand style suitable for the audience.
• Liaise between business, technology teams, and support teams.
• Align with the company's Global IT Policies & Procedures.
• Lead department investigations for minor deviations and associated CAPAs.
• Perform other duties as assigned.

• Possible experience with Enterprise Software preferred (SampleManager LIMS).
• One to three years of GMP experience or other highly regulated industry experience required. Some exposure to computer validation within a manufacturing or quality environment required.
• Strong attention to detail.
• Strong oral and written communication skills.
• Demonstrates self-discipline and motivation in all aspects of job performance.
• Experience with System Development Lifecycle methodologies and validated systems.
• Strong problem-solving skills.
• Ability to communicate technical concepts to both technical and non-technical audiences.
• Able to complete assignments with minimal direction.
• Must be able to work in a fast-paced team environment, balance multiple tasks, and react quickly to networking problems and issues.
• Must adapt to constantly evolving technologies.
• Bolstered PC knowledge and skills with Microsoft products.
• Interest in growing one's knowledge in the technology industry.

• Relevant technical certificates are a plus.