Specialist Quality Control - LIMS implementation Specialist Quality Control - LIMS implementation 1 week ago Be among the first 25 applicants
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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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