Qa Document And Training Manager

GCP/GLP QA Document and Training Manager

$65-77/hr, DOE

Remote/WFH

6 month Contract

The GCP/GLP QA Document and Training Manager will be responsible for formatting, review, issuance, and control of procedures, work instructions, forms, and test methods throughout the organization. The Documentation Specialist will also assist to maintain all employees training files and training curriculum, to ensure employees remain current in assigned training.

Job Responsibilities:

• Advise cross functionally to identify document type, impacted stakeholders, and review cycle including conflict resolution and approval.
• Perform administrative activities for QualityDocs and Training as the administrative user role
• Provide training status companywide and escalate risk and issues
• Reformat documents and configure tokens fit for Veeva
• Provide customer support to authors and approvers regarding creation, reviewing, revising, and obsoleting procedural documents.
• Perform bulk upload of legacy documents
• Responsible for the end-to-end lifecycle of documents in Veeva.
• Upload training materials
• Identify (with stakeholders) document changes that impact regulations and escalate to appropriate owner or quality assurance.
• Ensure training requirements are identified and implemented.
• Work with cross functional teams to set up Learner Roles and Curricula and add to Veeva
• Create Templates for fillable forms for Veeva

Qualifications:

· Bachelor’s degree in Chemistry or Biological Science

· 7+ years’ experience in biopharmaceutical industry

· Familiar with US FDA, EMA, and ICH regulations and guidelines

· Knowledge of QA systems and GCP/GLP compliance requirements

· Proven track record working in a multi-functional team environment

· Prior Veeva QualityDocs and/or Training implementation experience or administrator role

· Strong oral and written communication skills needed

· Excellent interpersonal skills