Title: Seeking a Quality Assurance Document Supervisor in Charlotte, NC
Introductory Paragraph:
We are excited to offer an outstanding opportunity for the right candidate! Our client is seeking a talented and experienced QA Documents Supervisor to join their team. As one of the leading pharmaceutical companies based in Charlotte, North Carolina our client has been at forefront of delivering innovative products that have helped improve millions of lives around the world.
Job Summary:
Our ideal candidate will be responsible for overseeing all aspects related to document control within our quality assurance department. This involves managing individuals who perform batch record reviews while ensuring compliance with regulatory requirements set forth by FDA guidelines.
Responsibilities include but not limited too:
- Develop and manage procedures associated with documentation
- Ensure cGMP (Current Good Manufacturing Practices) standards are followed accordingly
- Review documents such as Standard Operating Procedures (SOPs), Master Batch Records MBR's)
- Provide training on how these processes should be conducted effectively.
Qualifications:
The successful applicant must possess qualifications or experience relevant keywords like Pharmaco/USA/EPM/QA Specialist including :
- Bachelor's degree preferably in Science or Engineering disciplines required; advanced degree preferred
- 5+ years' experience working within Pharma/Biotech industry specifically focused on GxP regulations
- Knowledgeable about electronic systems used commonly formulating medical devices/pharmaceutical drugs
Skills Required:
In addition to possessing necessary qualification(s), applicants should also demonstrate proficiency/capacity regarding following skills :
1) Strong communication abilities both written & verbal,
2) Demonstrated leadership capacity
3 ) Ability work without supervision when needed;
4 ) Critical thinking/problem-solving capabilities