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QA Document Specilaist (GMP) - Oncology Biotech

QA Document Specilaist (GMP) - Oncology Biotech

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QA Document Specilaist (GMP) - Oncology Biotech

  • Location:

    New Jersey

  • Sector:

    Quality Assurance & Validation - Pharma

  • Contact:

    Ryan Goodland

  • Salary:

    US$45 - US$56 per hour

  • Job type:


  • Contact email:

  • Job ref:

    QA GMP_1684400930

  • Published:

    11 months ago

  • Duration:

    12 months

  • Startdate:


  1. Assist with site documentation needs ensuring GMP compliance of day-to-day operations: In this role, you will help with the management and control of various documents related to GMP, ensuring that they meet the necessary compliance standards.

  2. Support the Document Control Team with the formatting of procedural and technical documents, MBRs, and other GMP-related documents: You will work closely with the Document Control Team to format and organise different types of documents, including procedural documents, technical documents, Master Batch Records (MBRs), and other GMP-related documents.

  3. Process documents through the Veeva Quality Management System according to corporate and site procedures: You will be responsible for processing documents using the Veeva Quality Management System, following the established procedures of both the corporate office and the specific site.

  4. Undertake any other duties, either for this department or any other department within the business, which may be requested by the Line Manager, for which training and/or an explanation has been provided and understood: As directed by your Line Manager, you may be required to perform additional duties within your own department or other departments within the company. You will receive appropriate training and explanations for these tasks.

Skills required for the role:

  1. General GMP knowledge: You should have a good understanding of Good Manufacturing Practices (GMP), which are regulations and guidelines that ensure the quality and safety of pharmaceutical and biotech products.

  2. Organisational and time management skills: As a QA Document Coordinator, you must possess strong organisational and time management skills to effectively handle multiple tasks and meet deadlines.

  3. Experience with using Quality Management Systems such as Veeva Vault: Familiarity with Quality Management Systems, particularly Veeva Vault, is desired. This system is likely used for document control and management within the company.

  4. Advanced knowledge of Microsoft Word including shortcuts and formatting tools: Proficiency in Microsoft Word is essential, including knowledge of shortcuts and formatting tools. You will be responsible for formatting documents, so attention to detail is important.

  5. Excellent attention to detail, with the ability to work accurately in a busy and demanding environment: Given the nature of the role, meticulous attention to detail is required. You should be able to work accurately even in a fast-paced and demanding work environment.

  6. Strong collaboration and communication skills: Effective collaboration and communication skills are necessary as you will be working with different teams and departments within the company.

  7. Ability to successfully work within strict timelines: The role may involve working within tight deadlines, so you should be able to manage your time effectively and deliver work on schedule.