Job Title: Sr. Quality Assurance/Regulatory Affairs Analyst
Job Summary:
Mullan Pharmaceutical Inc., a fast-growing pharmaceutical product distribution company, is seeking a meticulous and detail-oriented Quality Assurance (QA) and Regulatory Affairs (RA) Analyst to join our team. The ideal candidate will be responsible for maintaining and enhancing the quality management systems to ensure the distribution of pharmaceutical products adheres to regulatory standards and meets the highest quality benchmarks.
Key Responsibilities:
1. Product Inspection and Release:
- Conduct rigorous quality inspections on incoming pharmaceutical products to ensure compliance with regulatory standards, industry specifications, and company guidelines.
- Perform regular inspections of manufacturer partners’ manufacturing processes, equipment, and facilities to ensure compliance with quality standards and regulation.
2. Regulatory Compliance:
- Stay abreast of relevant regulatory requirements and industry best practices in pharmaceutical wholesaling and distribution.
- Ensure all wholesaling activities align with local and international regulatory standards.
3. Documentation Management:
- Maintain and review quality-related documentation, including certificates of analysis, batch records, and other critical documents.
- Work closely with cross-functional teams to update and improve documentation processes.
4. Risk Management:
- Identify and assess potential risks in the wholesaling process, and work with stakeholders to implement risk mitigation strategies.
- Participate in the development and execution of contingency plans for quality-related issues.
5. Continuous Improvement:
- Implement and monitor key performance indicators (KPIs) to evaluate the effectiveness of quality processes within the wholesaling operation.
- Drive continuous improvement initiatives to enhance the efficiency and effectiveness of quality assurance activities.
Qualifications:
- Bachelor's degree in a relevant field (science, pharmacy, logistics, etc.).
- Thorough understanding of regulatory requirements for pharmaceuticals, including FDA and other international regulatory bodies.
- 5+ years of experience in quality assurance within the pharmaceutical wholesaler industry.
- Strong analytical skills and attention to detail.
- Excellent communication skills, both written and verbal.
- Knowledge of current Good Manufacturing Practice (cGMP) guidelines.
- Ability to collaborate effectively with internal and external stakeholders.
- Familiarity with quality management systems and documentation practices in the wholesaler sector.
Preferred Qualifications:
- Certification in Quality Assurance, Regulatory Affairs or a related field.
- Experience with electronic document management systems.
- Previous experience in a generic drug wholesaler company.
If you meet the specified qualifications and are passionate about maintaining high-quality standards in pharmaceutical wholesaling, we invite you to apply for this dynamic position at Mullan Pharmaceutical Inc.
Job Type: Full-time
Pay: $100,000.00 - $130,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Parental leave
- Vision insurance
Compensation package:
Experience level:
- 10 years
- 11+ years
- 5 years
- 6 years
- 7 years
- 8 years
- 9 years
Schedule:
Education:
Experience:
- regulatory affairs: 5 years (Required)
- pharmaceutical wholesaler: 5 years (Required)
Ability to Commute:
- Pasadena, CA 91101 (Required)
Work Location: In person