We are looking for skilled individuals who have knowledge, training and practice the principles of quality on a daily basis. The individual must be hard working, capable of working across departments, be able to learn and quickly take on responsibility, be extremely ambitious and be capable of leading a team.
Prevention of product deviations and defects is paramount in this role.
The quality management group is responsible for system wide quality, system implementation and process improvement. The Quality Management group is also responsible for all aspects of pharmaceutical quality assurance including component, intermediate, bulk and finished product release, equipment cleaning verification, qualifying equipment , document management, internal and external audits, regulatory relations, complaint handling, NDA submissions, cGMP training of employees, and other duties as assigned. As a senior member of this group the individual must be able to make decisions and immediately identify and address any issues or concerns with processes before they develop.
- Review, approval, and release of raw materials
- Support manufacturing and analytical services along with the QA team in all aspects of work to ensure proper procedure is being followed and any issues or concerns are discovered at the source before they develop.
- Document control through management, issuance, authoring, and approval of documents (SOPs, Monographs, Investigations)
- Qualify and manage equipment in the QA databases
- Interact with clients to build relationships to anticipate, meet, and exceed client expectations
- Responsible for the training of all employees with regards to quality and cGMP
- Developing business through new quotations, seeking new clients, interaction with current clients
- Lead supplier, client and FDA audits
- Build and improve quality systems
Keys to Success
- Must be a self-starter and capable of working with minimal oversight and able to manage a team
- Create value for the position, department and company
- Proactive Quality by Design, not reactive auditing, root cause analysis
- Must understand and participate in prevention and be able to improve systems and procedures as applicable
- Must be able to work in a fast paced and changing environment and know how to prioritize activities appropriately
- Must be able to understand and develop the business, understand the business as a whole and have involvement in the businesses cash flow where necessary
- Must understand and apply quality
Education & Experience Requirements
- Minimum of a Bachelor's Degree in a related science field to an accredited US college or university
- Drug development, New Drug Applicant and Regulatory Experience is required
- Salaried employees are compensated for a 50 hour work week
- Background and Credit Check required as part of the hiring process
Posting ID: 566865397Posted: 2020-08-05