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QA Documentation Admin

Abacus Service Corporation

This is a Full-time position in Melville, NY posted October 1, 2021.

The QA Documentation Admin is responsible for administrative functions necessary to migrate procedures from local system to the global system.

This includes moving document contents to global template, creating documents (+metadata) in global system, and obtaining re-approval of migrated procedures while ensuring compliance with SOP, cGMP and FDA requirements.

Major Accountabilities

Collaborates with department leadership ensuring timely migration of documents as per project plan.

Moves content from local document into updated template and ensures accuracy of content from source document to new document.

Creates documents in global system and accurately inputs assigned metadata.

Obtaining re-approval of migrated procedures in global system (e.g. follow-up with doc approvers)

Adheres to all applicable local procedures, cGMP’s, company policies, as well as other quality or regulatory requirements (OSHA, DEA, FDA, HS&E, etc.).

Ensures all work is performed in a safe, effective manner, and in compliance with the appropriate procedures.

Other duties as deemed necessary

Skills:

Excellent verbal and written communication skills

Quick learner; possessing initiative and troubleshooting ability

Capable of collaborating and building working relationships internal and external to the QA department

Highly proficient in MS Word.

Proficient on MS Excel and Outlook.

Strong team player: open to assisting with any task in order to get the work completed

Strong organizational skills: demonstrated ability to manage multiple tasks simultaneously and able to react to shifting priorities to meet business need

Should possess initiative and be a self-starter

Must be professional and punctual

Education:

High School Diploma; degree or formal training in a business field preferred.

Clerical and MS application (Excel) experience required; prior experience in GxP environment preferred.

Job Requirements:

  • Required Skills:

    CGMP

    Documentation

    Excel

    FDA

    Metadata

    Additional Skills:

    Ms Excel

    Ms word

    Outlook

    QA

    Self-starter

    SOP

    Word

    Clerical

    Excellent verbal and written communication skills

    GXP

    Microsoft Excel

    Microsoft outlook

    Microsoft word

    Organizational skills

    Project plan

    Team player

    Training