QC Informatics System Analyst I at Perrigo
Posted in General Business 13 days ago.
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Location: Bronx, New YorkJob Description:
Quality • Bronx, New York
KNOWLEDGE, EXPERIENCE AND EDUCATION
- Minimum Education requirements: Bachelor degree.
- Two or more years' experience in a laboratory environment, with one plus years' experience in computer systems administration (i.e. SharePoint, LIMS, LES, SAP).
- Experience in computer scripting process of at least one system (for example: VBA, Method Builder (SmartLab), SQL, Java, etc.) Ability to test programming and interfaces is preferred, and the ability to debug programs is also preferred.
- Must work independently with minimum supervision and have demonstrated ability to effectively manage the life-cycle of informatics projects of varying complexity and cross-departmental, multi-site, and/or global scope.
- Demonstrated ability to develop an application technical knowledge base and transfer via training to end Users is required. Ability to interact with end users at many levels of the organization is necessary.
- Familiarity with IT&S Stage Gate project management methodology is preferred.
- Demonstrated strong leadership skills and communication skills are essential.
- A thorough working knowledge of cGMP, cGLP, other US FDA regulations, and ICH guidance documents is essential.
- Proficient at multi-tasking and working with details, but is also a strategic problem-solver.
- Ability to develop and work on cross functional teams and represent QC on Global teams.
Major Duties / Responsibilities
% of Time
1. Manage maintenance, problem solve, provide support for enhancements and oversight of all QC Informatics activities.
2. Support and collaborate with QC and IT&S BPA to support the deployment of laboratory informatics systems to multiple QC sites.
3. Evaluate and support laboratory informatics systems for continuous improvement opportunities.
4. Conduct training for QC Informatics (local and Global).
5. Perform periodic audits of cGMP applications for compliance with 21CFRPart 11 and participate in internal/external audits.
Potential to have "dotted line relationship" with QC Supervisor or Manager in a related area.
- Interacting with internal and external customers, and understanding how to professionally interact, document need, and respond in a timely manner.
- Working on a cross functional teams to achieve desired results.
- Coordinating with special project teams to drive projects and communicating with QC Management the status of special projects.
- Consulting with Business stakeholders to define improvement opportunities. Managing the communication process between parties for all improvement and expansion projects (IT&S, Business, & CSV).
- Developing & Managing relationships with IT&S and Laboratory computer system end users.
- Serving as primary liaison between stakeholders and IT&S, assuring the training of impacted users and confirming customer acceptance.
- Serving as mentor (technically and professionally) to other Informatics Technicians/Engineers.
Most Complex Problems
- Cross-departmental development of informatics platforms and understanding system management requirements.
- Participating on the Implementation of laboratory informatics improvement initiatives.
- May have some responsibility for coordinating the work of contractors.
- Analyzing existing tools and evaluating viability of solution to technological needs and providing recommendations to management.
- Research and recommend new informatics and supporting procedures used in the QC Laboratory.
- Development of protocols for data management in support of laboratory practices.
- Development of processes, which support the laboratory's goals for efficient, reliable, cost-effective testing protocols.
- Prepare training materials and standard operating procedures supporting the introduction of new technology to the lab.
- Monitoring and initiating necessary minor process revisions to ensure efficient and effective process flow.
DECISION MAKING AUTHORITY
Typical decisions (total authority)
- Decisions with multiple options to solve problems. Uses judgments based on prior experience.
- Approval of customer COA/COC statements. Decisions referred to others for approval
- Purchase of laboratory information systems and other major capital expenditures.
- Significant process changes.
- Deviations from procedure.
- Approval of USP Compliance and APR statements.
- Off-site development opportunities.
An Equal Opportunity Employer - M/F/D/V
Equal Employment Opportunity/M/F/disability/protected veteran status.