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location: Worcester, Massachusetts
job type: Contract
salary: $25.00 - 29.80 per hour
work hours: 9 to 5
- Project Coordinator II, Quality Control Services will be responsible for overseeing of outsourced analytical GMP activities (CTLs) for late phase clinical and commercial programs from initial feasibility through method qualification, and routine release and stability testing.
- Technical and program management support of outsourced GMP/GxP release and stability programs.
- Oversight of analytical technology transfer and feasibility, method validation, and routine release and stability testing at CTL vendors.
- Review of release and stability testing data.
- Supports the coordination with Quality and Program Managers to provide project updates, workflows, and timelines.
- Author technical documentation (e.g. SOPs) with appropriate level of guidance, as needed.
- Can make presentations on validation and release/stability activities.
- 3+ years of experience in Quality Control / GMP laboratories is required.
- Experience with vendor management of CTLs is preferred.
- Excellent team skills, organization, and strong.
skills: Quality control, SOP, GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.