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Validation Specialist

Company: TalentBurst, an Inc 5000 company
Location: Swiftwater
Posted on: September 23, 2022

Job Description:

Position: Validation Specialist
Location: Swiftwater, PA
Duration: 5 months

Job Description:
Duties:
Experience in cleaning validation in the biologics or vaccine industry to include the following:

* Experience in authoring, reviewing, executing and approving validation documents
* Interface with Quality organization and the ability to defend rationale in validation documents
* Ability to review and analyze data
* Cleaning Validation experience
* Acceptance criteria determination
* Sampling procedures, 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

Basic Qualifications:

* 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

Skills:

* 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.

Education:

* BS/MS in Science (e.g. Chemistry, Biochemistry, Analytical Chemistry) or Engineering (Chemical or Biochemical) with 4+ total years of experience working in a biologic, vaccine or pharma industry.

Keywords: TalentBurst, an Inc 5000 company, Scranton , Validation Specialist, Other , Swiftwater, Pennsylvania

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