QC Laboratory Systems Specialist

Position Title: Specialist Quality Control

Work Arrangement: Local Holly Springs, NC hybrid candidate to report to the site when needed.

Work Location: Holly Springs, NC 27540

Assignment Duration: 6 months

Position Summary:

• Support QC ELN Project, including system validation/qualification deployment, eProcedure qualification, instrument report parsing script qualification, and masterdata templating associated with Laboratory System Upgrade.

Background & Context:

• Manager is open to aptitude over depth of experience if the candidate shows promise.
• Why is the Position Open: Planned Project.

Top 3 Must-Have Skill Sets:

• Experience with implementing new computerized laboratory systems, Leadership experience, and Ability to work independently.

Qualification & Experience:

• Doctorate degree OR Master's degree and 2 years of experience OR Bachelor's degree and 4 years of experience OR Associate's degree and 8 years of experience OR High school diploma / GED and 10 years of experience.
• The ideal candidate will have at least 4 years of experience supporting the implementation or validation of electronic quality systems, preferably within a GMP-regulated pharmaceutical or medical device environment.
• They should be comfortable working independently, possess strong technical documentation skills, and have hands-on experience building, configuring, or validating systems, not just using them.
• Prior involvement in global or cross-functional IT system projects is preferred.

Day-to-Day Responsibilities:

• Support ELN project as ANC representative. Will perform all work in the electronic system required to implement change to system at site level. Will represent ANC.

Key Responsibilities:

• Support validation/qualification deployment.
• Lead eProcedure qualification in LMES in support of Global QC Method Specific eProcedure creation/qualification project.
• Manage CIMS template creation for Global QC method-specific reagents/ and ANC consumables.
• Provide incident management support as required.
• Support application performance monitoring and label printing issues.
• Identify operational gaps and propose solutions.
• Assist in the execution of QC Laboratory Systems equipment integration for all ANC QC Laboratories.
• Responsible for training our organization NC site as each QC Laboratory systems go live in the production environment.
• Author, revise, and review documents and reports including SOPs, qualification reports, technical reports.
• Lead planning, scheduling, and execution of QC Laboratory Systems' daily activities.