Quality Lab System Specialist

3 weeks ago

Sanford, United States Insight Global Full time

Must haves:

  • Strong understanding of setting up computerized systems in laboratory setting
  • GMP experience
  • Experience in at least 1-2 lab management systems
  • Experience or familiarity with validation on lab equipment
  • Familiarity with ALCOA

Day to Day:

The position will support the Quality Operations department by performing QO System Administrative activities associated with the Quality Control Laboratories. This position requires the demonstrated capability to lead/provide strategic direction to DI and System Administrator projects (for example, computerized system maintenance) by defining project solution, strategies and insuring effective implementation and delivery as part of the overall project execution plan. Key responsibilities are performing Data Integrity (DI) assessment projects and then leading/managing the resulting remediation activities (for example, System upgrade project). This includes implementing DI control strategies (both technical and procedural controls) in the lab and influencing the DI/Compliance culture across the QC Organization and troubleshooting of connectivity type instrument/equipment/computer issues. Additional responsibilities include providing support for lab instrument validation activities. Also, must create, own and maintain QC DI documentation (e.g. DI Plan, DI procedures, and DI training materials). Additionally, performing change controls for QC document revisions, creating/reviewing/executing/approving activates for GMP tasks/activities associated with maintaining compliant Quality Control laboratories, participating in investigations of events, acting as a change agent and driving continuous improvement/Operational Excellence/innovative implementations, representing Quality Control on cross functional teams; and leads projects and/or teams providing guidance/training/coaching to junior colleagues.

The individual should be able to demonstrate the following:

• Acting safely, knows and follows all EH&S safety requirements for site and QC laboratories; leads safety initiatives and encourages others to act safely

• Recognized as a DI (ALCOA) and Compliance Subject Matter Expert or that supports audit and investigations, reviewing/approving technical content to ensure compliance to regulations and policies and standards

• Demonstrate solid understanding of laboratory instrument validation

• Recognized as a ‘go-to” person for computer system troubleshooting and having extensive technical knowledge of lab data systems and the related instrumentation used within QC

• Independent thinker with strong organizational skills, thinking from both a tactical and strategic basis for site-based projects or global programs (i.e. DI global initiatives, and/or global interfaces)

• Demonstrate process understanding to drive troubleshooting and optimization using automation tools and system technology

• Collaborate with site and off-site Digital (BT) colleagues to troubleshoot issues and to develop and deliver innovative solutions, best practices, and technical guidelines.

• Excellent effective written and verbal communication and interpersonal skills; established relationships within business lines

• Ability to identify issues, presents complex problems with possible solutions, and actively takes leadership role to resolve or independently resolves complex issues

• Applies discipline’s principles, appropriate procedures, and leadership skills to develop action plans and contributes to executing toward individual, team, and project goals

• Expertly solving highly complex problems and solving situation dependent multifaceted problems using even only ambiguous information

• Decision making that includes impact awareness on future quality and compliance as well as impact on own work group, department, and site

• Delivery on large and complex high business impact projects/activities/changes

• Displays strong investigative or technological orientation with independence for design of projects and able to make significant independent contributions to the implementation new systems

• Act as system administrator for laboratory instrumentations and associated software.

• Support additional system administration related activities within QC Laboratories such as data archival activities, equipment and electronic system implementation and troubleshooting, maintenance of end user accounts, equipment considerations relating to DI, etc.

• Basic understanding of networked computer systems and active directory.

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