Project Associate
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Your Role:
The Project Associate is responsible for assisting the Quality Control Management in oversight of operations within the Quality Control group. Responsibilities include leading or coordinating projects within safety, quality, scheduling, stability, metrics, regulatory and testing. Specific responsibilities include:
- Coordinating the product shelf-life stability program including:
- Scheduling of stability testing
- Document preparation including protocols and summary reports
- Routine coordination of QC testing to support production schedules including:
- Testing and schedule entry into Quality Control Management System (QCMS)
- Regular QC and cross-functional team communications for workflow prioritization to ensure testing meets lab goals and established timelines
- Test plan and batch record creation and revision
- Project management of:
- Method, instrument and computer data system qualifications and validations
- Lab advancement initiatives
- Corrective Action Preventative Action (CAPA), deviation and change control
- Coordinate completion of OOT and OOS investigations and actions
- Review of product, raw material and custom analytical testing records for accuracy, completeness, and compliance for release to Quality Assurance review
- Schedule production and stability projects for testing to avoid backorders and supply distribution This includes:
- Timely scheduling of projects into QCMS in accordance with production and customer needs
- Review and revision of test plans
- Assigning appropriate due dates
- Manage retest and stability program
- Collaborating with QC management to develop QC strategies and plans to optimize group performance
- Timely review of finished product and validation records
- Coordinate thorough and timely completion of OOT and OOS investigations and associated action items
- Identify quality issues and alerting management
- Lead or coordinating special projects and initiatives to improve QC lab safety, production and quality
- Performing other duties as assigned by the Lab Manager
Who You Are:
Basic Qualifications:
- Bachelor’s Degree in Chemistry, Chemical Engineering, or other Life Science discipline
- 2+ years of quality control experience
Preferred Qualifications:
- Working knowledge of the ISO 9001, 17025 and 17034
- Working knowledge of GxP (GLP/GMP)
RSREMD
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
Apply now and become a part of our diverse team!
If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.emdgroup.com/en/company/press-positions.html
Nearest Major Market: Austin
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QC, Quality Assurance, QA, Developer, CAPA, Quality, Technology, Management