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Job Description
Senior Associate Quality Control NPI: responsible for ensuring the quality of tasks and services provided, contributing to team milestones and projects.
**Job Description:**
- QC Representative for NPI activities and routine Product meetings
- Assist with QC projects and/or QC tasks within Site projects
- Plan and perform non-core testing related to NPI activities
- Manage all sample management activities related to NPI activities throughout the site
- Create/own and approve protocols, sample plans, SOP and documentation related to NPI
- Responsible for Method Validation and Transfers co-ordination and readiness
- Responsible for their own training and safety compliance
- Sample shipments and temperature monitoring activities for NPI activities
- LIMS data coordination of non-core (NPI) activities
- Participate in audits, initiatives and projects that may be departmental or organizational in scope
- Write protocols and perform assay validation and equipment qualification/ verification
- Introduce new techniques to the lab, including method transfers, reports, validations and protocols
- May contribute to regulatory filings
- May conduct lab investigations as necessary
- Evaluate lab practices for compliance on a continuous basis
- Approve lab results
- May represent the department/organization on various teams
- Create APPX data files and randomisation memo to facilitate data analysis
**Requirements:**
- Bachelors degree in a science discipline
- Approximately 2-3 years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry
- Strong background in Chemistry and Analytical testing is required