QA Documentation Manager

Location: Buena, NJ

Job Summary:

The Primary responsibility for this position is to manage the documentation for the facility and Change Controls, SOP’s, Specifications and labeling for the Buena, NJ Facility.

Essential Responsibilities:

  • Responsible for all documentation which is managed and stored by QA.
  • The documentation must be stored and organized as to be easily accessible for all audits.
  • Review, approve and trend Change Controls for the entire Buena, NJ facility.
  • Maintain and approve SOP’s for all departments.
  • Mange the review and approval of all labeling for production as well as maintaining the inventory.
  • Keep management updated on Change Controls, SOP’s, Labeling and Specifications.
  • Develop and or improve SOP’s for quality systems, such as Change Control, SOP’s, Labeling, and Specifications.
  • Develop and work with staff as a mentor and cross training in all areas of responsibility.
  • Perform all other duties as needed by upper management.

Qualifications:

  • Minimum of 5 years of experience in Quality Assurance and regulatory compliance in the pharmaceutical industry, preferably with generic pharmaceuticals.
  • Bachelor’s degree in a science or technical discipline (Chemistry, Biology, Microbiology, Engineering)
  • Minimum 2 years’ experience supervising personnel.
  • Familiarity with FDA, ICH and UP requirements for multiple dosage forms, including topical, ophthalmic, injectable and complex drug forms; willingness and ability to develop knowledge in these areas as the business expands in scope and complexity.
  • Able to manage shifting priorities and stay focused on long term goals and timelines.
  • Must be a team player.

This job description is not all-inclusive. It acts as a guideline and is subject to change over time. Additional duties may be assigned based on business needs

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