Azzur Group is a GxP compliance and consulting organization focused on providing quality-driven solutions that propel life science companies toward success. We are currently seeking candidates who are passionate about ensuring the highest standards of quality in the pharmaceutical and biotechnology sectors. If you're a dedicated professional with a desire to engage, learn, and adapt within a dynamic healthcare landscape, you will fit right into our core values: Put Others First, Have the Courage to Take Action, Take Personal Responsibility, and Have Fun!
We are currently seeking a meticulous Manufacturing Floor QA Consultant to join our team. This role will be critical in ensuring that all manufacturing processes comply with quality standards and regulatory requirements. The ideal candidate will have a strong background in quality assurance and an understanding of Good Manufacturing Practices (GMP), and will play a pivotal role in supporting manufacturing operations to maintain product quality and compliance.
Key Responsibilities:
- Conduct on-site quality assurance inspections and audits of manufacturing operations to ensure adherence to established protocols and regulatory guidelines.
- Assess and approve manufacturing documentation, including batch records, deviation reports, and change control documents.
- Collaborate with manufacturing teams to provide guidance on quality-related issues and promote a culture of quality throughout operations.
- Facilitate quality assessments and investigations into manufacturing discrepancies and implement corrective actions as necessary.
- Monitor compliance with cGMP and assist in the development and implementation of quality systems that enhance operational performance.
- Conduct training sessions on quality standards, shelf life studies, and documentation practices for manufacturing staff.
- Work alongside cross-functional teams to ensure seamless communication and coordination for continuous improvement of quality processes.
- Participate in internal and external audits, providing support and expertise to address findings or areas for improvement.
Qualifications:
- Bachelor’s degree in Life Sciences, Quality Assurance, or a related field.
- 2-3 years of experience in quality assurance within the pharmaceutical, biotechnology, or related regulated industry.
- Experience in packaging and pharmaceutical industry QA regulations.
- Thorough knowledge and understanding of cGMP regulations and industry best practices.
- Strong analytical skills, attention to detail, and problem-solving abilities.
- Excellent interpersonal and communication skills to work effectively with all levels of staff.
- Experience with quality management systems, documentation practices, and audit processes.
- Open to working on a 24 hr manufacturing cycle
- Willingness to work on the manufacturing floor and collaborate closely with cross-functional teams.
- Health Care Plan (Medical, Dental & Vision)
- Retirement Plan (401k)
- Life Insurance (Basic, Voluntary & AD&D)
- Paid Time Off (Vacation, Sick & Public Holidays)
Azzur Group is an equal opportunity employer and promotes a diverse culture in our workplace. We believe that promoting diversity plays an important role in developing top-quality talent, fostering greater innovation and creativity, and enhancing our relationships with customers and the communities in which we operate. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.