Location: Buena, NJ
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.
- 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.
- 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