Senior Validation Specialist
2 weeks ago
Pay Range $74.97hr - $78.97hr
- Experience in authoring, reviewing, executing and approving validation documents.
- Interface with Quality organization and the ability to defend rationale in validation documents.
- Ability to develop cleaning cycle and lead the investigation or trouble shooting.
- Ability to review and analyze data.
- Cleaning Validation experience.
- Acceptance criteria determination.
- Sampling plans and sample size determination.
- Rinse and Swab sampling experience.
- Bracketing and worse case rating.
- QC testing requirements.
- Dirty hold times and clean hold times.
- Experience utilizing Microsoft Word, Excel, and Outlook.
- Experience writing and revising documents (e.g. testing methods, protocols, reports).
- Experience performing testing in a GMP setting.
- MS Project experience.
- Proficiency in utilizing documentation system to author protocols and reports
- Experience participating in teams and collaborative work environments.
- Good communication skills (verbal and written), math skills, general computer skills
- Team environment a must.
- E Doc/GEODE+ experience with a working knowledge of templates, workflows and approval process.
- Strong root cause analysis with cGMP experience.
- BS/MS in Science (e.g. Chemistry, Biochemistry, Analytical Chemistry) or Engineering (Chemical or Biochemical) with 2+ total years of experience working in a biologic, vaccine or pharma industry.
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