USA-Validation Specialist III

Found in: Talent US C2 - 2 weeks ago

Swiftwater, United States eTeam Inc Full time

Duties

________________________________________

1. Experience in cleaning validation in the biologics or vaccine industry to include the following:

1. Experience in authoring, reviewing, executing and approving validation documents

2. Interface with Quality organization and the ability to defend rationale in validation documents

3. Ability to review and analyze data

2. Cleaning Validation experience

1. Acceptance criteria determination

2. Sampling procedures, plans and sample size determination

3. Rinse and Swab sampling experience

4. Bracketing and worse case rating

5. QC testing requirements

6. 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

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