Specialist Quality Control - LIMS implementation

Infotree Global Solutions; Holly Springs (NC); Remote; Full time

Job summary

A leading company in biotechnology is seeking a Specialist in Quality Control to support QC ELN Projects. The role involves system validation, document management, and training for the North Carolina site. Ideal candidates will possess strong implementation experience in pharmaceutical Quality Control Systems and relevant educational qualifications, with responsibilities that include incident management and operational support.

Qualifications

• Advanced education qualifications ranging from high school diploma to Doctorate.
• Strong background in Quality Control Systems in pharmaceuticals.
• At least 2 years of relevant experience for Master’s level or 4 years for Bachelor’s.

Responsibilities

• Lead eProcedure qualification in LMES for QC projects.
• Manage CIMS template creation for Global QC methods.
• Train Client NC site as QC laboratory systems go live.

Skills

Quality Control Systems implementation

Education

Doctorate degree OR Masters degree and 2 years of experience OR Bachelors degree and 4 years of experience OR Associates degree and 8 years of experience OR High school diploma / GED and 10 years of experience

Job description

Specialist Quality Control - LIMS implementation

Specialist Quality Control - LIMS implementation

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Remote with willingness to travel as needed up to 50% (NC Plant)

This position will support QC ELN Project, including but not limited to, system validation/qualification deployment, eProcedure qualification, instrument report parsing script qualification and masterdata templating associated with Laboratory System Upgrade (CIMS (Reagent Manager)/LMES (Smart Lab eProcedure).

• 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 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 QC Laboratories.

• Responsible for training the Client 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.

Basic Qualifications

Doctorate degree OR Masters degree and 2 years of experience OR Bachelors degree and 4 years of experience OR Associates degree and 8 years of experience OR High school diploma / GED and 10 years of experience

Top 3 Must Have Skill Sets:

• Quality Control Systems implementation experience in the pharmaceutical industry is required.

Day to Day Responsibilities:

• Lead eProcedure qualification in LMES in support of QC Method Specific eProcedure creation/qualification project.
• Manage CIMS template requests for all QC Groups.
• Author, revise, and review documents and reports including SOPs, qualification reports, technical reports supporting QC Systems (LMES/CIMS).
• Lead training workshops for the Client NC site as each QC Laboratory system goes live in the production environment.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Job function

  Other

• Industries

  Staffing and Recruiting and Biotechnology Research

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