QC Support Group Leader

GSK•Zebulon, NC

11d•Onsite

About The Position

Effectively lead a team of laboratory equipment scientists and systems analysts to provide business support to the Zebulon site. Ensure the successful delivery of compliant instrumentation, systems, and control systems and maintain routine support of QC activities. This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: Lead and supervise a team of laboratory systems, analytical methods, and equipment expert to provide daily support to the QC teams, overall systems and equipment maintenance, and analytical method support, deploy updates, as needed. Ensure appropriate equipment validation and analytical standards are in-place/in-use throughout the equipment lifecycle. Participate on inter-departmental project teams (with both on-site and central teams) by providing leadership and decision making. Serve as a point-of-contact for internal and external audits. Drive continuous improvement within the team, identify and remove waste, and adopt standardized approaches, where possible. Ensure laboratory systems analytical methods, and equipment meets requirements for safety and quality and focus on support and updates that meet business needs. Develop and revise departmental SOPs, system/equipment lifecycle documentation (PVR, user maintenance, system audits, equipment task lists, etc.), and technical reports. Ensure these comply with guidance documents (QMS, AEQMS, CAPs, Industry guidelines, etc.). Provide clear leadership in the development of team personnel. Oversee and provide leadership for implementation of new systems or changes to existing systems, analytical methods and equipment ensuring PIPs, change controls and validation documentation is completed in a compliant, effective manner aligned with the delivery timelines required by the project and laboratory demand.

Requirements

Bachelor's degree in a Science, Engineering or related discipline.
6+ years' experience as a systems analyst and/or equipment SME.
Developing knowledge and application of the equipment validation requirements.
Strong skills with troubleshooting for systems and equipment.
Experience of leading work in teams to improve processes or resolve problems using GPS tools.

Nice To Haves

Ability to interface with operational and management teams within the organization.
Flexible while remaining focused to drive for results.
Experience in most, or all, of the systems lifecycle (i.e., strategy, prioritization, design, development, implementation and operations) stages.
Leadership skills with ability to lead and provide oversight to laboratory equipment and systems projects.
Able to properly align a team of systems analysts and laboratory equipment SMEs to focus on daily support and project deployment in support of site and company strategy.
Knowledge of the change control process governing system and equipment lifecycle.
Effective verbal and written communication skills.

Responsibilities

Lead and supervise a team of laboratory systems, analytical methods, and equipment expert to provide daily support to the QC teams, overall systems and equipment maintenance, and analytical method support, deploy updates, as needed.
Ensure appropriate equipment validation and analytical standards are in-place/in-use throughout the equipment lifecycle.
Participate on inter-departmental project teams (with both on-site and central teams) by providing leadership and decision making.
Serve as a point-of-contact for internal and external audits.
Drive continuous improvement within the team, identify and remove waste, and adopt standardized approaches, where possible.
Ensure laboratory systems analytical methods, and equipment meets requirements for safety and quality and focus on support and updates that meet business needs.
Develop and revise departmental SOPs, system/equipment lifecycle documentation (PVR, user maintenance, system audits, equipment task lists, etc.), and technical reports.
Ensure these comply with guidance documents (QMS, AEQMS, CAPs, Industry guidelines, etc.).
Provide clear leadership in the development of team personnel.
Oversee and provide leadership for implementation of new systems or changes to existing systems, analytical methods and equipment ensuring PIPs, change controls and validation documentation is completed in a compliant, effective manner aligned with the delivery timelines required by the project and laboratory demand.