Specialist Quality Control (ELN/Implementation Quality Systems)

Infotree Global Solutions; Holly Springs (NC); On-site; USD 70,000 - 90,000; Full time

Job summary

A leading company in the pharmaceutical sector is seeking a Specialist in Quality Control to support various quality initiatives. This role involves leading eProcedure qualification processes, managing templates for quality control, and training personnel on new systems. Candidates should have significant experience in quality control systems implementation, particularly in the pharmaceutical industry.

Qualifications

• Experience in pharmaceutical industry quality control systems.
• Strong document authoring and review skills.
• Capability to lead system qualification activities.

Responsibilities

• Lead eProcedure qualification in LMES.
• Manage CIMS template requests.
• Provide training and support during QC systems go-live.

Skills

Quality Control Systems implementation experience

Job description

Specialist Quality Control (ELN/Implementation Quality Systems)

Specialist Quality Control (ELN/Implementation Quality Systems)

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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 Client 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 Client QC Laboratories.

• Responsible for training the Client 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.

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

Seniority level

• Seniority level

  Associate

Employment type

• Employment type

  Contract

Job function

• Job function

  Manufacturing

• Industries

  Staffing and Recruiting and Pharmaceutical Manufacturing

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