Quality Systems Specialist
Work situation: Fully onsite
A mid-size Pharmaceutical company is seeking a Quality Systems Specialist to join their team. The ideal candidate will have strong experience with MasterControl and a proven track record in developing and enhancing quality management systems. This role involves working closely with cross-functional teams to build and maintain a robust quality system that supports our company's commitment to excellence and regulatory compliance.
The Quality System Specialist will have the following responsibilites:
- Design, develop, and implement quality management systems to ensure compliance with regulatory requirements and industry standards.
- Lead initiatives to enhance and streamline existing quality systems and processes.
- Utilize MasterControl software to manage document control, change control, CAPA (Corrective and Preventive Actions), and other quality system modules.
- Configure and maintain MasterControl system settings, workflows, and user permissions to optimize system performance.
- Ensure that all quality management documentation, including SOPs, work instructions, and policies, are up-to-date and compliant with regulatory requirements.
- Assist in internal and external audits by providing necessary documentation and support.
- Provide training and support to staff on quality system procedures and MasterControl functionality.
- Develop training materials and conduct workshops to improve understanding and implementation of quality processes.
The Quality System Specialist should have the following qualifications:
- Bachelor’s degree in a relevant field (e.g., Quality Assurance, Engineering, Life Sciences).
- Minimum of 3 years of experience in quality systems management, with a strong focus on MasterControl.
- In-depth knowledge of quality management principles, practices, and regulatory requirements (e.g., FDA, ISO, GMP).
- Proven experience in designing, implementing, and maintaining quality management systems.
- Strong analytical skills and attention to detail.
- Excellent communication and interpersonal skills.
- Ability to work independently and as part of a team in a fast-paced environment.
- Experience with other quality management software systems is a plus.
Benefits:
- Competitive compensation package
- 401k match
- Full health benefit plan
- Ample growth opportunity